Trial Outcomes & Findings for A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer (NCT NCT01322490)

NCT ID: NCT01322490

Last Updated: 2019-09-04

Results Overview

The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1297 participants
• Primary outcome timeframe: Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study.
• Results posted on: 2019-09-04

Participant Flow

Phase 3, randomized, placebo-controlled, multicenter, multi-country efficacy trial of PROSTVAC administered SC to adult males with asymptomatic mCRPC, and was designed to enroll approximately 1200 men. Subjects were randomly assigned with equal probability (1:1:1) to one of three double-blind treatment arms.

Screening activities were completed within 28 days prior to the first dose of any medication and were completed prior to dosing. Subjects who required anti-androgen wash-out specifically for this protocol were consented prior to beginning withdrawal of therapy, however, no other screening procedures were performed the subject was deemed eligible.

Participant milestones

Measure	PROSTVAC-V/F-TRICOM + GM-CSF Placebo PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).	PROSTVAC-V/F-TRICOM + GM-CSF PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).	Placebo Control Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
Treatment Period STARTED	432	432	433
Treatment Period Treated	429	429	428
Treatment Period COMPLETED	300	279	280
Treatment Period NOT COMPLETED	132	153	153
Long Term Follow-up Period STARTED	409	408	413
Long Term Follow-up Period COMPLETED	0	0	0
Long Term Follow-up Period NOT COMPLETED	409	408	413

Reasons for withdrawal

Measure	PROSTVAC-V/F-TRICOM + GM-CSF Placebo PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).	PROSTVAC-V/F-TRICOM + GM-CSF PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).	Placebo Control Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
Treatment Period Adverse Event	12	18	15
Treatment Period Death	5	7	3
Treatment Period Lack of Efficacy	89	100	112
Treatment Period Physician Decision	0	2	1
Treatment Period Protocol Violation	7	5	4
Treatment Period Withdrawal by Subject	14	16	11
Treatment Period Non-compliance with study drug	0	0	1
Treatment Period Other per report	2	2	1
Treatment Period Randomized but Not Treated	3	3	5
Long Term Follow-up Period Death	235	239	236
Long Term Follow-up Period Lost to Follow-up	2	2	3
Long Term Follow-up Period Withdrawal by Subject	9	6	6
Long Term Follow-up Period Study Terminated by Sponsor	160	158	165
Long Term Follow-up Period Other per report	3	2	2
Long Term Follow-up Period Unknown/Missing	0	1	1

Baseline Characteristics

A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

Baseline characteristics by cohort

Measure	PROSTVAC-V/F-TRICOM + GM-CSF Placebo n=432 Participants PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).	PROSTVAC-V/F-TRICOM + GM-CSF n=432 Participants PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).	Placebo Control n=433 Participants Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).	Total n=1297 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	104 Participants n=5 Participants	121 Participants n=7 Participants	109 Participants n=5 Participants	334 Participants n=4 Participants
Age, Categorical >=65 years	328 Participants n=5 Participants	311 Participants n=7 Participants	324 Participants n=5 Participants	963 Participants n=4 Participants
Age, Continuous	71.3 years STANDARD_DEVIATION 8.00 • n=5 Participants	70.6 years STANDARD_DEVIATION 8.42 • n=7 Participants	71.4 years STANDARD_DEVIATION 8.33 • n=5 Participants	71.1 years STANDARD_DEVIATION 8.25 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	432 Participants n=5 Participants	432 Participants n=7 Participants	433 Participants n=5 Participants	1297 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants	40 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	418 Participants n=5 Participants	421 Participants n=7 Participants	415 Participants n=5 Participants	1254 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	25 Participants n=7 Participants	23 Participants n=5 Participants	65 Participants n=4 Participants
Race (NIH/OMB) White	404 Participants n=5 Participants	400 Participants n=7 Participants	403 Participants n=5 Participants	1207 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment Puerto Rico	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	124 Participants n=5 Participants	141 Participants n=7 Participants	129 Participants n=5 Participants	394 Participants n=4 Participants
Region of Enrollment United Kingdom	31 Participants n=5 Participants	29 Participants n=7 Participants	39 Participants n=5 Participants	99 Participants n=4 Participants
Region of Enrollment Iceland	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment Russia	50 Participants n=5 Participants	52 Participants n=7 Participants	61 Participants n=5 Participants	163 Participants n=4 Participants
Region of Enrollment Spain	45 Participants n=5 Participants	33 Participants n=7 Participants	48 Participants n=5 Participants	126 Participants n=4 Participants
Region of Enrollment Canada	30 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants	69 Participants n=4 Participants
Region of Enrollment Netherlands	6 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Region of Enrollment Belgium	12 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Region of Enrollment Denmark	34 Participants n=5 Participants	42 Participants n=7 Participants	32 Participants n=5 Participants	108 Participants n=4 Participants
Region of Enrollment Poland	6 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	20 Participants n=4 Participants
Region of Enrollment Israel	13 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment Australia	36 Participants n=5 Participants	38 Participants n=7 Participants	27 Participants n=5 Participants	101 Participants n=4 Participants
Region of Enrollment France	29 Participants n=5 Participants	28 Participants n=7 Participants	28 Participants n=5 Participants	85 Participants n=4 Participants
Region of Enrollment Germany	3 Participants n=5 Participants	13 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Region of Enrollment Estonia	7 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Randomization Stratum PSA < 50 ng/mL and LDH < 200 U/L	168 Participants n=5 Participants	168 Participants n=7 Participants	168 Participants n=5 Participants	504 Participants n=4 Participants
Randomization Stratum PSA < 50 ng/mL and LDH >= 200 U/L	135 Participants n=5 Participants	135 Participants n=7 Participants	135 Participants n=5 Participants	405 Participants n=4 Participants
Randomization Stratum PSA >= 50 ng/mL and LDH < 200 U/L	65 Participants n=5 Participants	64 Participants n=7 Participants	64 Participants n=5 Participants	193 Participants n=4 Participants
Randomization Stratum PSA >= 50 ng/mL and LDH >= 200 U/L	64 Participants n=5 Participants	65 Participants n=7 Participants	66 Participants n=5 Participants	195 Participants n=4 Participants

PRIMARY outcome

Timeframe: Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study.

Population: Intent to treat, including all randomized subjects.

The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.

Outcome measures

Measure	PROSTVAC-V/F-TRICOM + GM-CSF Placebo n=432 Participants PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).	PROSTVAC-V/F-TRICOM + GM-CSF n=432 Participants PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).	Placebo Control n=433 Participants Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
Overall Survival	34.4 Months Interval 31.0 to 36.9	33.2 Months Interval 30.6 to 37.4	34.3 Months Interval 30.7 to 37.0

SECONDARY outcome

Timeframe: Randomization through Week 25/End of Treatment visit.

Population: Intent to treat, including all randomized subjects.

A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such.

Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death.

Outcome measures

Measure	PROSTVAC-V/F-TRICOM + GM-CSF Placebo n=432 Participants PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).	PROSTVAC-V/F-TRICOM + GM-CSF n=432 Participants PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).	Placebo Control n=433 Participants Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
Number of Subjects Alive Without Event at 6 Months	127 Participants	121 Participants	131 Participants

Adverse Events

PROSTVAC-V/F-TRICOM + GM-CSF Placebo

Serious events: 56 serious events

Other events: 351 other events

Deaths: 252 deaths

PROSTVAC-V/F-TRICOM + GM-CSF

Serious events: 56 serious events

Other events: 367 other events

Deaths: 254 deaths

Placebo Control

Serious events: 53 serious events

Other events: 346 other events

Deaths: 248 deaths

Serious adverse events

Measure	PROSTVAC-V/F-TRICOM + GM-CSF Placebo n=429 participants at risk PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).	PROSTVAC-V/F-TRICOM + GM-CSF n=429 participants at risk PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).	Placebo Control n=428 participants at risk Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
Blood and lymphatic system disorders Anaemia	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Blood and lymphatic system disorders Febrile neutropenia	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Blood and lymphatic system disorders Haemolytic uraemic syndrome	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Blood and lymphatic system disorders Histiocytosis haematophagic	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Cardiac disorders Acute coronary syndrome	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Cardiac disorders Acute myocardial infarction	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Cardiac disorders Angina pectoris	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Cardiac disorders Atrial fibrillation	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.70% 3/428 • Number of events 4 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Cardiac disorders Atrial flutter	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Cardiac disorders Cardiac failure	0.47% 2/429 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Cardiac disorders Mitral valve incompetence	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Cardiac disorders Myocardial infarction	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Cardiac disorders Myocardial ischaemia	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Cardiac disorders Supraventricular tachycardia	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Ear and labyrinth disorders Vertigo	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Eye disorders Retinal detachment	0.23% 1/429 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Constipation	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Diarrhoea	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Gastritis	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Ileus	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Ileus paralytic	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Inguinal hernia	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Inguinal hernia strangulated	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Large intestinal obstruction	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Nausea	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/428 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Proctitis	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Vomiting	0.47% 2/429 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Death	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders General physical health deterioration	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Non-cardiac chest pain	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Pain	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/429 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Pyrexia	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Hepatobiliary disorders Cholelithiasis	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Appendiceal abscess	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Bacterial infection	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Bronchopneumonia	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Catheter site infection	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Cellulitis	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Gastroenteritis	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Gastroenteritis viral	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Lobar pneumonia	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Oral candidiasis	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Perinephric abscess	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Pneumonia	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/429 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Pyelonephritis	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Sepsis	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Spinal cord infection	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/429 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Staphylococcal sepsis	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Urinary tract infection	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.70% 3/429 • Number of events 3 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Urosepsis	0.47% 2/429 • Number of events 3 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/428 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Viral infection	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Brain herniation	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Cystitis radiation	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Fall	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Gun shot wound	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Hepatic haematoma	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Radiation oesophagitis	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Spinal cord injury	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Sternal fracture	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Injury, poisoning and procedural complications Vascular bypass dysfunction	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Investigations Blood creatinine increased	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Investigations Troponin increased	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Metabolism and nutrition disorders Cell death	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Metabolism and nutrition disorders Dehydration	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Metabolism and nutrition disorders Diabetes mellitus	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Metabolism and nutrition disorders Gout	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Musculoskeletal and connective tissue disorders Bone pain	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/428 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma in situ of skin	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pain	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/428 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Carotid artery stenosis	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Cerebral haematoma	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Cerebral haemorrhage	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Cerebrovascular accident	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/429 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Cervical cord compression	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Ischaemic stroke	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/429 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Nerve compression	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Presyncope	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Radiculopathy	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Spinal cord compression	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.93% 4/429 • Number of events 4 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/428 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Syncope	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/428 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Transient ischaemic attack	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Psychiatric disorders Confusional state	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Psychiatric disorders Delirium	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Acute kidney injury	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Dysuria	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Haematuria	0.47% 2/429 • Number of events 4 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	1.6% 7/429 • Number of events 8 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.93% 4/428 • Number of events 4 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Hydronephrosis	1.2% 5/429 • Number of events 5 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/428 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Obstructive uropathy	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Pyelocaliectasis	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Renal failure	0.47% 2/429 • Number of events 3 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Ureteric obstruction	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Urethral stenosis	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/428 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Urinary bladder haemorrhage	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Urinary retention	1.4% 6/429 • Number of events 6 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.93% 4/429 • Number of events 4 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Renal and urinary disorders Urinary tract obstruction	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.47% 2/429 • Number of events 2 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.2% 5/429 • Number of events 5 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Vascular disorders Aortic aneurysm	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Vascular disorders Aortic stenosis	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Vascular disorders Intermittent claudication	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Vascular disorders Lymphoedema	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Vascular disorders Vascular compression	0.23% 1/429 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/428 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Vascular disorders Venous thrombosis limb	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.00% 0/429 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	0.23% 1/428 • Number of events 1 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.

Other adverse events

Measure	PROSTVAC-V/F-TRICOM + GM-CSF Placebo n=429 participants at risk PROSTVAC V/F + Placebo GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).	PROSTVAC-V/F-TRICOM + GM-CSF n=429 participants at risk PROSTVAC V/F + GM-CSF, where PROSTVAC V is given SC at 2x10\^8 Inf.U/0.5mL (Day 1) and PROSTVAC F is given SC at 1x10\^9 Inf.U/0.5mL (Weeks 3, 5, 9, 13, 17, 21). GM-CSF is given SC at 100ug (on days of PROSTVAC injection and three subsequent days).	Placebo Control n=428 participants at risk Placebo PROSTVAC V/F + Placebo GM-CSF, where Placebo PROSTVAC V/F is an empty fowlpox vector (Day 1, Weeks 3, 5, 9, 13, 17, 21). Placebo GM-CSF was saline for injection (on days of PROSTVAC injection and three subsequent days).
Gastrointestinal disorders Constipation	9.1% 39/429 • Number of events 44 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	6.1% 26/429 • Number of events 29 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	6.5% 28/428 • Number of events 31 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Diarrhoea	8.9% 38/429 • Number of events 41 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	6.5% 28/429 • Number of events 31 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	4.9% 21/428 • Number of events 22 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Gastrointestinal disorders Nausea	11.9% 51/429 • Number of events 65 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	11.9% 51/429 • Number of events 62 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	8.4% 36/428 • Number of events 41 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Asthenia	7.5% 32/429 • Number of events 46 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	8.6% 37/429 • Number of events 50 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	11.4% 49/428 • Number of events 52 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Chills	7.9% 34/429 • Number of events 50 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	10.3% 44/429 • Number of events 60 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	8.2% 35/428 • Number of events 42 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Fatigue	21.9% 94/429 • Number of events 117 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	24.5% 105/429 • Number of events 149 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	21.3% 91/428 • Number of events 116 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Influenza like illness	10.3% 44/429 • Number of events 68 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	12.8% 55/429 • Number of events 86 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	8.4% 36/428 • Number of events 63 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Injection site erythema	46.9% 201/429 • Number of events 594 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	59.7% 256/429 • Number of events 765 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	46.7% 200/428 • Number of events 626 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Injection site induration	10.7% 46/429 • Number of events 98 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	15.6% 67/429 • Number of events 140 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	13.6% 58/428 • Number of events 128 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Injection site oedema	5.1% 22/429 • Number of events 41 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	5.4% 23/429 • Number of events 47 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	4.4% 19/428 • Number of events 45 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Injection site pain	25.4% 109/429 • Number of events 252 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	29.8% 128/429 • Number of events 247 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	27.8% 119/428 • Number of events 247 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Injection site pruritus	17.9% 77/429 • Number of events 145 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	25.4% 109/429 • Number of events 235 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	13.3% 57/428 • Number of events 124 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Injection site swelling	17.0% 73/429 • Number of events 187 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	23.5% 101/429 • Number of events 247 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	15.7% 67/428 • Number of events 183 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Injection site warmth	3.5% 15/429 • Number of events 31 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	6.5% 28/429 • Number of events 55 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	4.9% 21/428 • Number of events 38 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Oedema peripheral	4.9% 21/429 • Number of events 22 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	5.6% 24/429 • Number of events 24 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	2.8% 12/428 • Number of events 12 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
General disorders Pyrexia	8.6% 37/429 • Number of events 50 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	21.2% 91/429 • Number of events 142 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	12.4% 53/428 • Number of events 63 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Infections and infestations Urinary tract infection	5.4% 23/429 • Number of events 28 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	4.0% 17/429 • Number of events 22 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	5.1% 22/428 • Number of events 28 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Metabolism and nutrition disorders Decreased appetite	9.1% 39/429 • Number of events 43 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	5.8% 25/429 • Number of events 29 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	7.2% 31/428 • Number of events 33 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	11.4% 49/429 • Number of events 70 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	11.7% 50/429 • Number of events 69 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	12.9% 55/428 • Number of events 71 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Musculoskeletal and connective tissue disorders Back pain	14.5% 62/429 • Number of events 70 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	10.0% 43/429 • Number of events 46 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	11.2% 48/428 • Number of events 55 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.5% 15/429 • Number of events 15 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	6.5% 28/429 • Number of events 33 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	4.9% 21/428 • Number of events 27 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Musculoskeletal and connective tissue disorders Myalgia	8.4% 36/429 • Number of events 46 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	8.2% 35/429 • Number of events 47 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	10.0% 43/428 • Number of events 61 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	6.5% 28/429 • Number of events 34 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	6.5% 28/429 • Number of events 28 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	5.4% 23/428 • Number of events 26 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Dizziness	4.2% 18/429 • Number of events 20 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	4.0% 17/429 • Number of events 19 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	5.1% 22/428 • Number of events 25 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Nervous system disorders Headache	7.5% 32/429 • Number of events 67 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	10.0% 43/429 • Number of events 61 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	8.4% 36/428 • Number of events 45 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Cough	5.8% 25/429 • Number of events 26 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	4.7% 20/429 • Number of events 24 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	3.5% 15/428 • Number of events 16 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Vascular disorders Hot flush	5.4% 23/429 • Number of events 24 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	4.7% 20/429 • Number of events 21 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	2.8% 12/428 • Number of events 15 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.
Vascular disorders Hypertension	6.5% 28/429 • Number of events 33 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	5.4% 23/429 • Number of events 26 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.	5.1% 22/428 • Number of events 25 • Treatment-Emergent AEs were collected from the date of first dose of investigational product through 28 days post-last dose of investigational product, approximately 6 months post-first vaccination for subjects completing the treatment period. All-Cause Mortality was collected for each subject from randomization through death, loss to follow-up, or study closure. Total follow-up lasted approximately 6 years, from the first subject randomized to the completion of the study. An AE was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. For the purpose of this clinical trial, AEs included only Treatment-Emergent AEs that were either new or represented detectable exacerbations of pre-existing conditions. Only treated subjects were assessed for adverse events.

Additional Information

Program Lead, Clinical Operations

Bavarian Nordic A/S

Phone: + 45 3326

Email: info@bavarian-nordic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place