Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011) (NCT NCT01254630)

NCT ID: NCT01254630

Last Updated: 2019-09-30

Results Overview

Clinical criteria for suspected HZ cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 5305 participants
• Primary outcome timeframe: Up to approximately 5 years
• Results posted on: 2019-09-30

Participant Flow

Adult participants with a diagnosis of solid tumor malignancy (STM) or hematologic malignancy (HM) were enrolled from 328 sites.

Out of 5507 screened participants, 5305 were randomized. Twenty randomized participants were not included in analyses: 19 participants from a single site identified to have major Good Clinical Practice compliance issues and 1 participant that was not vaccinated. Thus, a total of 5285 were included in analyses.

Participant milestones

Measure	V212-STM Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	V212-HM Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-STM Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-HM Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.
Overall Study STARTED	1348	1288	1364	1285
Overall Study Received Vaccination 1	1328	1277	1350	1275
Overall Study Received Vaccination 2	1255	1217	1286	1226
Overall Study Received Vaccination 3	1198	1178	1247	1194
Overall Study Received Vaccination 4	1155	1145	1212	1160
Overall Study COMPLETED	546	0	552	0
Overall Study NOT COMPLETED	802	1288	812	1285

Reasons for withdrawal

Measure	V212-STM Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	V212-HM Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-STM Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-HM Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.
Overall Study Adverse Event	36	15	40	8
Overall Study Death	461	151	478	139
Overall Study Lost to Follow-up	80	26	89	32
Overall Study Physician Decision	24	8	16	7
Overall Study Withdrawal by Subject	201	94	188	89
Overall Study Study terminated by sponsor	0	994	0	1010
Overall Study Status not recorded	0	0	1	0

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011)

Baseline characteristics by cohort

Measure	V212-STM n=1348 Participants Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	V212-HM n=1288 Participants Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-STM n=1364 Participants Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-HM n=1285 Participants Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Total n=5285 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 11.5 • n=5 Participants	61.0 years STANDARD_DEVIATION 14.9 • n=7 Participants	57.7 years STANDARD_DEVIATION 11.5 • n=5 Participants	61.4 years STANDARD_DEVIATION 14.5 • n=4 Participants	59.4 years STANDARD_DEVIATION 13.3 • n=21 Participants
Age, Customized Adults (between 18 and 64 years)	965 Participants n=5 Participants	705 Participants n=7 Participants	981 Participants n=5 Participants	673 Participants n=4 Participants	3324 Participants n=21 Participants
Age, Customized From 65 to 84 years	379 Participants n=5 Participants	558 Participants n=7 Participants	378 Participants n=5 Participants	589 Participants n=4 Participants	1904 Participants n=21 Participants
Age, Customized 85 years and over	4 Participants n=5 Participants	25 Participants n=7 Participants	5 Participants n=5 Participants	23 Participants n=4 Participants	57 Participants n=21 Participants
Age, Customized <50 years	299 Participants n=5 Participants	235 Participants n=7 Participants	320 Participants n=5 Participants	223 Participants n=4 Participants	1077 Participants n=21 Participants
Age, Customized ≥50 years	1049 Participants n=5 Participants	1053 Participants n=7 Participants	1044 Participants n=5 Participants	1062 Participants n=4 Participants	4208 Participants n=21 Participants
Sex: Female, Male Female	867 Participants n=5 Participants	528 Participants n=7 Participants	892 Participants n=5 Participants	523 Participants n=4 Participants	2810 Participants n=21 Participants
Sex: Female, Male Male	481 Participants n=5 Participants	760 Participants n=7 Participants	472 Participants n=5 Participants	762 Participants n=4 Participants	2475 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	17 Participants n=5 Participants	2 Participants n=7 Participants	14 Participants n=5 Participants	2 Participants n=4 Participants	35 Participants n=21 Participants
Race (NIH/OMB) Asian	55 Participants n=5 Participants	110 Participants n=7 Participants	64 Participants n=5 Participants	94 Participants n=4 Participants	323 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Black or African American	86 Participants n=5 Participants	41 Participants n=7 Participants	92 Participants n=5 Participants	57 Participants n=4 Participants	276 Participants n=21 Participants
Race (NIH/OMB) White	1044 Participants n=5 Participants	976 Participants n=7 Participants	1031 Participants n=5 Participants	986 Participants n=4 Participants	4037 Participants n=21 Participants
Race (NIH/OMB) More than one race	144 Participants n=5 Participants	157 Participants n=7 Participants	159 Participants n=5 Participants	141 Participants n=4 Participants	601 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to approximately 5 years

Population: This analysis was based on the Modified Intent-to-Treat (MITT) population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.

Clinical criteria for suspected HZ cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure.

Outcome measures

Measure	V212-STM n=1328 Participants Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-STM n=1350 Participants Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.
Incidence of Confirmed Herpes-Zoster	6.737 Number of cases per 1000 person years Interval 4.222 to 10.2	18.457 Number of cases per 1000 person years Interval 14.118 to 23.709

PRIMARY outcome

Timeframe: Up to 28 days after vaccination 4 (up to approximately 118 days)

Population: The analysis population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.

Outcome measures

Measure	V212-STM n=1322 Participants Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-STM n=1346 Participants Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.
Percentage of Participants With One or More Serious Adverse Events	22.5 percentage of participants Interval 20.3 to 24.9	21.0 percentage of participants Interval 18.9 to 23.3

SECONDARY outcome

Timeframe: Up to 6 months after onset of HZ (up to approximately 5 years)

Population: This analysis was based on the MITT population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.

Moderate to severe HZ-associated pain was defined as 2 or more occurrences of a score of 3 or greater (0-to-10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the Zoster Brief Pain Inventory (ZBPI) at any time from HZ onset through the end of the 6 month HZ-follow-up period.

Outcome measures

Measure	V212-STM n=1328 Participants Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-STM n=1350 Participants Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.
Incidence of Moderate to Severe Herpes-Zoster-Associated Pain	2.144 Number of cases per 1000 person years Interval 0.862 to 4.417	9.380 Number of cases per 1000 person years Interval 6.373 to 13.314

SECONDARY outcome

Timeframe: Up to 6 months after onset of HZ (up to approximately 5 years)

Population: This analysis was based on the MITT population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.

The composite efficacy endpoint of the incidence of HZ complications was defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.

Outcome measures

Measure	V212-STM n=1328 Participants Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-STM n=1350 Participants Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.
Incidence of Herpes-Zoster Complications	0.306 Number of cases per 1000 person years Interval 0.008 to 1.706	2.421 Number of cases per 1000 person years Interval 1.045 to 4.77

SECONDARY outcome

Timeframe: Up to 6 months after onset of HZ (up to approximately 5 years)

Population: This analysis was based on the MITT population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.

Postherpetic Neuralgia (PHN) was defined as pain in the area of the HZ rash with pain in the last 24 hours scored as 3 or greater (on a 0 to 10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the ZBPI that persists or appears greater than or equal to 90 days after HZ rash onset.

Outcome measures

Measure	V212-STM n=1328 Participants Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-STM n=1350 Participants Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.
Incidence of Postherpetic Neuralgia	0.306 Number of cases per 1000 person years Interval 0.008 to 1.706	1.210 Number of cases per 1000 person years Interval 0.33 to 3.099

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 days after vaccination 4 (up to approximately 118 days)

Population: The analysis population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.

Outcome measures

Measure	V212-STM n=1322 Participants Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-STM n=1346 Participants Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.
Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event	2.2 percentage of participants	1.7 percentage of participants

Adverse Events

V212-STM

Serious events: 794 serious events

Other events: 857 other events

Deaths: 472 deaths

V212-HM

Serious events: 500 serious events

Other events: 779 other events

Deaths: 159 deaths

Placebo-STM

Serious events: 808 serious events

Other events: 759 other events

Deaths: 488 deaths

Placebo-HM

Serious events: 507 serious events

Other events: 559 other events

Deaths: 146 deaths

Serious adverse events

Measure	V212-STM n=1322 participants at risk Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	V212-HM n=1274 participants at risk Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-STM n=1346 participants at risk Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-HM n=1274 participants at risk Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.
Cardiac disorders Ventricular extrasystoles	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Ventricular fibrillation	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Ventricular tachycardia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Congenital, familial and genetic disorders Dysplastic naevus syndrome	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Cholecystitis chronic	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pyelonephritis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Anaemia	0.68% 9/1322 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.3% 16/1274 • Number of events 19 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.8% 24/1346 • Number of events 25 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.86% 11/1274 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Anaemia of malignant disease	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Febrile neutropenia	1.6% 21/1322 • Number of events 23 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	3.5% 44/1274 • Number of events 64 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	2.6% 35/1346 • Number of events 37 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	2.7% 35/1274 • Number of events 43 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Haematotoxicity	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Haemolysis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Haemolytic anaemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Hypoprothrombinaemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Iron deficiency anaemia	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Leukocytosis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Leukopenia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Lymph node pain	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Lymphadenopathy	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Neutropenia	0.30% 4/1322 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Pancytopenia	0.53% 7/1322 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.67% 9/1346 • Number of events 12 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Thrombocytopenia	0.38% 5/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Acute coronary syndrome	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Acute myocardial infarction	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.47% 6/1274 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Angina pectoris	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Angina unstable	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Aortic valve sclerosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Aortic valve stenosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Arrhythmia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Atrial fibrillation	0.53% 7/1322 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.71% 9/1274 • Number of events 12 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.82% 11/1346 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.2% 15/1274 • Number of events 15 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Atrial flutter	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Atrioventricular block second degree	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiac arrest	0.61% 8/1322 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiac failure	0.45% 6/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiac failure acute	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiac failure chronic	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiac failure congestive	0.68% 9/1322 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.86% 11/1274 • Number of events 12 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.78% 10/1274 • Number of events 15 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiac tamponade	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiac valve disease	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiac ventricular thrombosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardio-respiratory arrest	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiomyopathy	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiomyopathy acute	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiopulmonary failure	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Cardiorenal syndrome	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Congestive cardiomyopathy	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Coronary artery disease	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Coronary artery insufficiency	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Mitral valve incompetence	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Myocardial infarction	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Myocardial ischaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Palpitations	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Pericardial effusion	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Pericardial haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Pericarditis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Pulseless electrical activity	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Sinus node dysfunction	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Sinus tachycardia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Stress cardiomyopathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Supraventricular tachycardia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Tachycardia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Cardiac disorders Ventricular dyssynchrony	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Ear and labyrinth disorders Inner ear disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Ear and labyrinth disorders Neurosensory hypoacusis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Ear and labyrinth disorders Vertigo	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Ear and labyrinth disorders Vertigo positional	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Endocrine disorders Adrenal insufficiency	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Endocrine disorders Carcinoid syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Endocrine disorders Cushing's syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Endocrine disorders Goitre	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Endocrine disorders Hypercalcaemia of malignancy	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Endocrine disorders Hyperthyroidism	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Endocrine disorders Hypothyroidism	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Endocrine disorders Thyroid mass	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Eye disorders Blindness transient	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Eye disorders Cataract	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Eye disorders Cortical visual impairment	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Eye disorders Myopia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Eye disorders Necrotising retinitis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Eye disorders Retinal detachment	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Eye disorders Ulcerative keratitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Abdominal hernia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Abdominal hernia obstructive	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Abdominal pain	0.68% 9/1322 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.52% 7/1346 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Abdominal pain lower	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Abdominal pain upper	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Anal fissure	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Anal fistula	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Ascites	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Colitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Colitis ischaemic	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Constipation	0.53% 7/1322 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.59% 8/1346 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Crohn's disease	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Cyclic vomiting syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Diarrhoea	1.3% 17/1322 • Number of events 20 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.97% 13/1346 • Number of events 15 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Diverticular perforation	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Diverticulum	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Duodenitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Dyspepsia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Dysphagia	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Enteritis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Enterocutaneous fistula	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Eosinophilic colitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Erosive oesophagitis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Faecaloma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Gastritis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Gastritis erosive	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.53% 7/1322 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.47% 6/1274 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.97% 13/1346 • Number of events 13 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Gastrointestinal hypomotility	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Gastrointestinal obstruction	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Haematemesis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Haematochezia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Haemorrhoids	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Hiatus hernia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Ileus	0.15% 2/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Incarcerated inguinal hernia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Inguinal hernia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Inguinal hernia strangulated	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Intestinal fibrosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Intestinal ischaemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Intestinal obstruction	0.91% 12/1322 • Number of events 16 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.74% 10/1346 • Number of events 12 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Intestinal perforation	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Intestinal prolapse	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Large intestine perforation	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Large intestine polyp	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Mouth ulceration	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Nausea	0.30% 4/1322 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Obstruction gastric	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Odynophagia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Oesophageal perforation	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Oesophageal rupture	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Oesophagitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Pancreatic insufficiency	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Pancreatic mass	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Pancreatitis	0.30% 4/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Proctalgia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Proctitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Rectal ulcer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Salivary gland calculus	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Small intestinal obstruction	1.6% 21/1322 • Number of events 43 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.89% 12/1346 • Number of events 17 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Small intestinal perforation	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Stomatitis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Subileus	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Umbilical hernia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Volvulus	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Vomiting	0.83% 11/1322 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.97% 13/1346 • Number of events 16 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Adverse drug reaction	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Asthenia	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Chest discomfort	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Chest pain	0.45% 6/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.89% 12/1346 • Number of events 13 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.63% 8/1274 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Chills	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Complication associated with device	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Death	2.3% 31/1322 • Number of events 31 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.0% 13/1274 • Number of events 13 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.3% 17/1346 • Number of events 17 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.55% 7/1274 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Drug withdrawal syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Fatigue	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Gait disturbance	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders General physical health deterioration	0.38% 5/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Generalised oedema	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Granuloma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Impaired healing	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Incarcerated hernia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Malaise	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Medical device pain	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Mucosal haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Mucosal inflammation	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Multiple organ dysfunction syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Nodule	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Non-cardiac chest pain	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Oedema peripheral	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Organ failure	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Pain	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Polyserositis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Pyrexia	0.83% 11/1322 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.1% 15/1346 • Number of events 15 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.0% 13/1274 • Number of events 14 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Sudden death	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Systemic inflammatory response syndrome	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Ulcer haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Vascular stent thrombosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Visceral pain	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Bile duct obstruction	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Bile duct stone	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Biliary colic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Biloma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Cholangitis	0.30% 4/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.52% 7/1346 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Cholangitis acute	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Cholecystitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Cholecystitis acute	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Cholelithiasis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Cholestasis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Gallbladder disorder	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Haemobilia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Hepatic failure	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Hepatic haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Hepatitis cholestatic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Hepatorenal syndrome	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Hyperbilirubinaemia	0.08% 1/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Jaundice cholestatic	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Liver injury	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Immune system disorders Anaphylactic reaction	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Immune system disorders Drug hypersensitivity	0.30% 4/1322 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Immune system disorders Graft versus host disease	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Immune system disorders Hypersensitivity	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Immune system disorders Hypogammaglobulinaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Immune system disorders Sarcoidosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Abdominal abscess	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Abdominal infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Abdominal sepsis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Abdominal wall abscess	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Abscess jaw	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Abscess limb	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Abscess soft tissue	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Anal abscess	0.08% 1/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Appendicitis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Appendicitis perforated	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Arthritis bacterial	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Arthritis infective	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Atypical pneumonia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Bacillus bacteraemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Bacteraemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Bacterial sepsis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Bacterial tracheitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Biliary sepsis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Breast abscess	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Breast cellulitis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Bronchiolitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Bronchitis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.78% 10/1274 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.47% 6/1274 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Cellulitis	0.91% 12/1322 • Number of events 19 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.0% 13/1274 • Number of events 18 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.4% 19/1346 • Number of events 21 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.0% 13/1274 • Number of events 14 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Cellulitis staphylococcal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Cerebral aspergillosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Chronic sinusitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Citrobacter sepsis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Clostridial infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Clostridial sepsis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Clostridium difficile colitis	0.68% 9/1322 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Clostridium difficile infection	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Cystitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Dengue fever	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Device related infection	0.53% 7/1322 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.74% 10/1346 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Device related sepsis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Diarrhoea infectious	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Disseminated cryptococcosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Diverticulitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Empyema	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Encephalitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Endocarditis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Endophthalmitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Enteritis infectious	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Enterococcal sepsis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Epididymitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Erysipelas	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Escherichia bacteraemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Escherichia infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Escherichia sepsis	0.30% 4/1322 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Escherichia urinary tract infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Extradural abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Febrile infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Fungaemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Fungal oesophagitis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Gastroenteritis	0.45% 6/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Gastroenteritis salmonella	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Gastroenteritis viral	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Gastrointestinal infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Genital herpes	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Groin abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations H1N1 influenza	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Haematoma infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Haemophilus bacteraemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Hepatitis B	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Hepatitis C	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Hepatosplenic candidiasis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Herpes virus infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Herpes zoster	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Herpes zoster disseminated	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Herpes zoster oticus	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Implant site infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Infected bite	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Infected fistula	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Infected seroma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Infectious colitis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Infectious pleural effusion	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Influenza	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.47% 6/1274 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Intestinal fistula infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Joint abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Kidney infection	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Klebsiella bacteraemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Klebsiella sepsis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Labyrinthitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Listeria sepsis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Lower respiratory tract infection	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Lower respiratory tract infection fungal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Lung abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Lung infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Lung infection pseudomonal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Mediastinitis	0.08% 1/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Meningitis aseptic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Meningitis cryptococcal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Meningoencephalitis herpetic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Metapneumovirus infection	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Muscle abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Nasopharyngitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Necrotising fasciitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Neutropenic sepsis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Orchitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Osteomyelitis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Otitis media	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Paraspinal abscess	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pelvic abscess	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pelvic inflammatory disease	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Periodontitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Periorbital cellulitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Perirectal abscess	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Peritonitis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Peritonitis bacterial	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Peritonsillar abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pharyngitis streptococcal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pilonidal cyst	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pleurisy viral	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia	3.7% 49/1322 • Number of events 57 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.7% 72/1274 • Number of events 83 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	3.6% 49/1346 • Number of events 53 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.2% 66/1274 • Number of events 87 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia bacterial	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia cytomegaloviral	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia fungal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia influenzal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia klebsiella	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia moraxella	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia mycoplasmal	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia necrotising	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia pneumococcal	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia pseudomonal	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pneumonia streptococcal	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Post procedural cellulitis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Post procedural infection	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Post procedural sepsis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Postoperative wound infection	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Progressive multifocal leukoencephalopathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pseudomembranous colitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pseudomonal bacteraemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pseudomonal sepsis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Psoas abscess	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pulmonary sepsis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pyelonephritis acute	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Pyomyositis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Rectal abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Renal abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Respiratory moniliasis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Respiratory tract infection	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Respiratory tract infection bacterial	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Rhinovirus infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Scrotal infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Sepsis	2.1% 28/1322 • Number of events 32 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.3% 17/1274 • Number of events 18 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.6% 21/1346 • Number of events 23 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.6% 21/1274 • Number of events 22 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Sepsis syndrome	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Septic shock	0.45% 6/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.55% 7/1274 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.52% 7/1346 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.78% 10/1274 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Serratia bacteraemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Serratia sepsis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Sinusitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Skin infection	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Soft tissue infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Splenic abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Staphylococcal abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Staphylococcal bacteraemia	0.15% 2/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Staphylococcal infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Staphylococcal sepsis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Staphylococcal skin infection	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Stenotrophomonas sepsis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Subcutaneous abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Tonsillitis bacterial	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Tooth abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Tuberculosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Upper respiratory tract infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Urinary tract infection	1.4% 19/1322 • Number of events 20 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.86% 11/1274 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.8% 24/1346 • Number of events 24 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.86% 11/1274 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Urinary tract infection bacterial	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Urinary tract infection fungal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Urinary tract infection staphylococcal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Urosepsis	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Varicella	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Varicella zoster pneumonia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Viraemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Viral infection	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Vulval abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations West Nile viral infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Wound abscess	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Wound infection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Accidental overdose	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Anastomotic stenosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Chemical peritonitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Compression fracture	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Concussion	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Contusion	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Eschar	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Eye contusion	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Fall	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Femoral neck fracture	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Femur fracture	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Head injury	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Heat exhaustion	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Hip fracture	0.38% 5/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Humerus fracture	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Incarcerated incisional hernia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Incisional hernia	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Joint injury	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Laceration	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Lower limb fracture	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Osteoradionecrosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Overdose	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Post procedural bile leak	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Post procedural discharge	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Post procedural fistula	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Post procedural haematoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Postoperative respiratory distress	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Radiation necrosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Radiation oesophagitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Radiation pericarditis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Radiation pneumonitis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Radius fracture	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Seroma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Skin wound	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Spinal column injury	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Spinal compression fracture	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Sternal fracture	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Stoma site haemorrhage	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Stomal hernia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Stress fracture	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Subdural haematoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Thermal burn	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Toxicity to various agents	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Transplant dysfunction	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Urinary retention postoperative	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Urostomy complication	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Wound	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Investigations CSF test abnormal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Investigations Oxygen saturation decreased	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Investigations Prothrombin time abnormal	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Investigations Troponin increased	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Decreased appetite	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Dehydration	1.2% 16/1322 • Number of events 16 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.3% 17/1346 • Number of events 18 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Electrolyte imbalance	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Failure to thrive	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Fluid overload	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Food intolerance	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Gout	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Hypercalcaemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Hyperglycaemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Hypocalcaemia	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Hypoglycaemia	0.23% 3/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Hypokalaemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.55% 7/1274 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Hypomagnesaemia	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Hyponatraemia	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Hypovolaemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Malnutrition	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Metabolic alkalosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Back pain	0.30% 4/1322 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Bone cyst	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Fracture delayed union	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Muscular weakness	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Pain in extremity	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Soft tissue mass	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Synovial cyst	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute monocytic leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute promyelocytic leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.38% 5/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of appendix	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.68% 9/1322 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.74% 10/1346 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of salivary gland	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer recurrent	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer stage IV	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large cell lymphoma T- and null-cell types	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic oligodendroglioma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiocentric lymphoma recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Appendix cancer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B precursor type acute leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.71% 9/1274 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.6% 20/1274 • Number of events 20 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma refractory	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell small lymphocytic lymphoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell unclassifiable lymphoma low grade	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.68% 9/1322 • Number of events 12 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.55% 7/1274 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.67% 9/1346 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.86% 11/1274 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign renal neoplasm	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.38% 5/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm benign	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	7.1% 94/1322 • Number of events 98 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	6.4% 86/1346 • Number of events 89 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	2.0% 27/1322 • Number of events 27 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	3.0% 40/1346 • Number of events 40 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.89% 12/1346 • Number of events 12 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage IV	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchioloalveolar carcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix cancer metastatic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.59% 8/1346 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	4.2% 54/1274 • Number of events 56 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	4.9% 62/1274 • Number of events 67 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia transformation	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.55% 7/1274 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell sarcoma of soft tissue	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	4.2% 55/1322 • Number of events 61 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	4.7% 63/1346 • Number of events 71 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	2.5% 33/1322 • Number of events 35 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.8% 24/1346 • Number of events 27 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer recurrent	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage II	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage IV	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.76% 10/1322 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.59% 8/1346 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.38% 5/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.47% 6/1274 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma refractory	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal adenocarcinoma of pancreas	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Duodenal neoplasm	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.38% 5/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.52% 7/1346 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer metastatic	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage IV	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ependymoma malignant	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epiglottic carcinoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential thrombocythaemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ewing's sarcoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ewing's sarcoma metastatic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type) recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fallopian tube cancer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrous histiocytoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder adenocarcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Lymphoedema	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.91% 12/1322 • Number of events 13 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.82% 11/1346 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer recurrent	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal cancer metastatic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal melanoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.38% 5/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.59% 8/1346 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hairy cell leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Head and neck cancer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.86% 11/1274 • Number of events 12 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.55% 7/1274 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease lymphocyte depletion type stage unspecified	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma metastatic	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease mixed cellularity recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease nodular sclerosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease nodular sclerosis recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.45% 6/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.67% 9/1346 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratinising squamous cell carcinoma of nasopharynx	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large granular lymphocytosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer metastatic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Light chain disease	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma recurrent	0.08% 1/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.45% 6/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.15% 2/1322 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.45% 6/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	3.9% 52/1322 • Number of events 52 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	3.5% 47/1346 • Number of events 51 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage III	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphocytic lymphoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.47% 6/1274 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Orthostatic hypotension	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma transformation	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoplasmacytoid lymphoma/immunocytoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoplasmacytoid lymphoma/immunocytoma recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant histiocytosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of ampulla of Vater	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.23% 3/1322 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary carcinoma of breast	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma malignant	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to ovary	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to rectum	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mucinous adenocarcinoma of appendix	0.15% 2/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mycosis fungoides	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mycosis fungoides recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.94% 12/1274 • Number of events 14 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.55% 7/1274 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome transformation	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloid leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma metastatic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.3% 17/1274 • Number of events 17 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.78% 10/1274 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma metastatic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma unspecified histology aggressive	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	1.7% 22/1322 • Number of events 23 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.3% 18/1346 • Number of events 23 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer recurrent	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IIIB	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma metastatic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.38% 5/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.1% 15/1346 • Number of events 15 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteosarcoma metastatic	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteosarcoma recurrent	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	2.0% 27/1322 • Number of events 30 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	2.2% 29/1346 • Number of events 32 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.45% 6/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer recurrent	0.45% 6/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer recurrent	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.98% 13/1322 • Number of events 13 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.3% 17/1346 • Number of events 18 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour metastatic	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peripheral T-cell lymphoma unspecified	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peripheral T-cell lymphoma unspecified recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peritoneal carcinoma metastatic	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peritoneal neoplasm	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	4.2% 54/1274 • Number of events 54 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	4.2% 54/1274 • Number of events 57 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.63% 8/1274 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmablastic lymphoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Precursor T-lymphoblastic lymphoma/leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Precursor T-lymphoblastic lymphoma/leukaemia recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.1% 15/1322 • Number of events 17 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.74% 10/1346 • Number of events 14 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.30% 4/1322 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	1.9% 25/1322 • Number of events 34 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.3% 17/1346 • Number of events 18 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.68% 9/1322 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.52% 7/1346 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer recurrent	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Refractory anaemia with an excess of blasts	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma metastatic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma of skin	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Signet-ring cell carcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer metastatic	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.53% 7/1322 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer extensive stage	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Splenic marginal zone lymphoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.47% 6/1274 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of head and neck	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.30% 4/1322 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.47% 6/1274 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.78% 10/1274 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the hypopharynx	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma recurrent	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell type acute leukaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer metastatic	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsillar neoplasm	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyosarcoma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal cancer	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Waldenstrom's macroglobulinaemia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Aphasia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Brain oedema	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Carotid artery aneurysm	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Carotid artery stenosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Cerebellar infarction	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Cerebral haematoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Cerebral haemorrhage	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Cerebral infarction	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Cerebral microangiopathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Cerebrovascular accident	0.61% 8/1322 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Cervical cord compression	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Cognitive disorder	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Cubital tunnel syndrome	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Dementia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Depressed level of consciousness	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Diabetic coma	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Dizziness	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Embolic stroke	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Encephalopathy	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Epilepsy	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Facial paralysis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Guillain-Barre syndrome	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Haemorrhage intracranial	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Headache	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Hemiparesis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Hepatic encephalopathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Hypoglycaemic coma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Intensive care unit acquired weakness	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Intracranial haematoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Ischaemic stroke	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Lumbar radiculopathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Meningeal disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Migraine	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Myelitis transverse	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Nervous system disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Neuralgia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Neuropathy peripheral	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Parkinson's disease	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Polyneuropathy	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Post herpetic neuralgia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Presyncope	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Sciatica	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Seizure	0.45% 6/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Senile dementia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Serotonin syndrome	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Simple partial seizures	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Spinal cord compression	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Syncope	0.38% 5/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Toxic encephalopathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Transient ischaemic attack	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Vasogenic cerebral oedema	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Vocal cord paralysis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Product Issues Device dislocation	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Product Issues Device failure	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Product Issues Device leakage	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Product Issues Device malfunction	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Product Issues Device occlusion	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Product Issues Stent malfunction	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Product Issues Thrombosis in device	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Adjustment disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Anxiety	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Confusional state	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Delirium	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Depression	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Major depression	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Mania	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Mental disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Mental status changes	0.38% 5/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Mood altered	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Somatic symptom disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Psychiatric disorders Suicide attempt	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Acute kidney injury	0.91% 12/1322 • Number of events 12 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.78% 10/1274 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.3% 18/1346 • Number of events 20 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.78% 10/1274 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Chronic kidney disease	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.24% 3/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders End stage renal disease	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Haematuria	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Hydronephrosis	0.30% 4/1322 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Hypercalcaemic nephropathy	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Incontinence	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Micturition disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Nephrolithiasis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Obstructive uropathy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Renal failure	0.38% 5/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Renal impairment	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Stag horn calculus	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Ureteric obstruction	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Ureterolithiasis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Urinary retention	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Adnexa uteri mass	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Colpocele	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Endometrial hyperplasia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Genital erosion	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Genital lesion	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Metrorrhagia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Ovarian cyst	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Ovarian disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Ovarian mass	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Prostatic disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Prostatic dysplasia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Testicular pain	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Vaginal disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Acute interstitial pneumonitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.68% 9/1322 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Aspiration	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.76% 10/1322 • Number of events 14 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.63% 8/1274 • Number of events 19 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.74% 10/1346 • Number of events 13 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.55% 7/1274 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.38% 5/1322 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.45% 6/1346 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Paranasal sinus mucosal hypertrophy	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.83% 11/1322 • Number of events 12 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.89% 12/1346 • Number of events 14 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.78% 10/1274 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pneumonia lipoid	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.30% 4/1322 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.37% 5/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.1% 28/1322 • Number of events 28 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.55% 7/1274 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.4% 19/1346 • Number of events 20 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.39% 5/1274 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Reactive airways dysfunction syndrome	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Respiration abnormal	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.23% 3/1322 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.45% 6/1322 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.59% 8/1346 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Vocal cord thickening	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Angioedema	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Brow ptosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Eczema nummular	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Generalised erythema	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Skin necrosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Skin reaction	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Accelerated hypertension	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Aortic aneurysm	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Aortic dissection	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Aortic stenosis	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Arterial thrombosis	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Circulatory collapse	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Deep vein thrombosis	1.1% 14/1322 • Number of events 14 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.47% 6/1274 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.89% 12/1346 • Number of events 12 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.55% 7/1274 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Embolism	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Haematoma	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Haemorrhage	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Hypertension	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Hypertensive crisis	0.08% 1/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Hypertensive emergency	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Hypotension	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.30% 4/1346 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.31% 4/1274 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Hypovolaemic shock	0.15% 2/1322 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Pelvic venous thrombosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.07% 1/1346 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Peripheral artery occlusion	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Peripheral embolism	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Peripheral ischaemia	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Peripheral venous disease	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.16% 2/1274 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Subclavian vein thrombosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Superior vena cava syndrome	0.08% 1/1322 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Thrombosis	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.15% 2/1346 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Vascular disorders Venous thrombosis limb	0.00% 0/1322 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1274 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.00% 0/1346 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.08% 1/1274 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.

Other adverse events

Measure	V212-STM n=1322 participants at risk Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	V212-HM n=1274 participants at risk Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-STM n=1346 participants at risk Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.	Placebo-HM n=1274 participants at risk Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered \~30 days apart.
Blood and lymphatic system disorders Anaemia	8.2% 108/1322 • Number of events 127 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	4.0% 51/1274 • Number of events 61 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	8.5% 114/1346 • Number of events 140 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	2.7% 35/1274 • Number of events 36 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Neutropenia	6.7% 89/1322 • Number of events 121 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.8% 23/1274 • Number of events 25 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	6.8% 92/1346 • Number of events 125 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	2.2% 28/1274 • Number of events 32 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Blood and lymphatic system disorders Thrombocytopenia	5.1% 67/1322 • Number of events 88 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.1% 14/1274 • Number of events 15 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	4.6% 62/1346 • Number of events 77 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.9% 24/1274 • Number of events 28 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Constipation	4.8% 63/1322 • Number of events 68 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	2.3% 29/1274 • Number of events 33 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	6.0% 81/1346 • Number of events 97 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	3.0% 38/1274 • Number of events 42 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Diarrhoea	9.5% 126/1322 • Number of events 160 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.5% 70/1274 • Number of events 83 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	10.2% 137/1346 • Number of events 181 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.4% 69/1274 • Number of events 87 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Nausea	12.3% 163/1322 • Number of events 222 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	6.5% 83/1274 • Number of events 125 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	12.5% 168/1346 • Number of events 215 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	6.2% 79/1274 • Number of events 105 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Gastrointestinal disorders Vomiting	6.1% 80/1322 • Number of events 103 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	2.7% 35/1274 • Number of events 51 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	6.8% 92/1346 • Number of events 104 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	4.1% 52/1274 • Number of events 65 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Fatigue	10.3% 136/1322 • Number of events 159 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.6% 71/1274 • Number of events 74 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	11.6% 156/1346 • Number of events 179 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.2% 66/1274 • Number of events 72 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Injection site erythema	28.1% 371/1322 • Number of events 865 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	30.5% 389/1274 • Number of events 875 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	2.4% 32/1346 • Number of events 40 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.3% 68/1274 • Number of events 89 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Injection site pain	23.5% 311/1322 • Number of events 650 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	29.3% 373/1274 • Number of events 741 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.8% 78/1346 • Number of events 103 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	8.4% 107/1274 • Number of events 151 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Injection site pruritus	5.1% 68/1322 • Number of events 106 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	7.4% 94/1274 • Number of events 153 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.22% 3/1346 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	0.55% 7/1274 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Injection site swelling	22.0% 291/1322 • Number of events 663 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	25.8% 329/1274 • Number of events 715 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.9% 25/1346 • Number of events 32 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	4.0% 51/1274 • Number of events 63 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
General disorders Pyrexia	14.9% 197/1322 • Number of events 325 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	14.1% 180/1274 • Number of events 291 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	14.7% 198/1346 • Number of events 361 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	11.4% 145/1274 • Number of events 247 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Infections and infestations Nasopharyngitis	2.9% 38/1322 • Number of events 40 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.5% 70/1274 • Number of events 84 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	4.3% 58/1346 • Number of events 63 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.6% 71/1274 • Number of events 88 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Headache	7.1% 94/1322 • Number of events 137 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	8.4% 107/1274 • Number of events 172 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	8.5% 114/1346 • Number of events 192 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	7.5% 95/1274 • Number of events 172 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Nervous system disorders Neuropathy peripheral	5.2% 69/1322 • Number of events 77 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.0% 13/1274 • Number of events 13 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.6% 76/1346 • Number of events 86 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	1.7% 22/1274 • Number of events 22 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 66/1322 • Number of events 71 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.3% 68/1274 • Number of events 76 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.4% 73/1346 • Number of events 77 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.	5.1% 65/1274 • Number of events 71 • Adverse events were collected up to approximately 5 years after vaccination 1. The All Subjects as Treated population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER