Trial Outcomes & Findings for Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation (NCT NCT02388165)

NCT ID: NCT02388165

Last Updated: 2021-01-05

Results Overview

BSI: clinical infection involved a recognized pathogen (S. aureus) cultured from 1 or more blood cultures or a commensal organism cultured from 2 or more blood cultures whether primary or secondary to infection at another site. SSI: infection at a surgical incision. Types of SSI in this outcome measure: Deep incisional SSI: infection involved deep soft tissues of incision (example \[e.g.\] fascial and muscle layers), Organ/space SSI: infection involved any part of body excluding skin incision, fascia or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative BSI and/or SSI (including deep incisional or organ/space), caused by S. aureus, occurred within 90 days of post elective open posterior spinal fusion surgery with multilevel instrumentation, as confirmed by event adjudication committee (EAC) have been reported. A participant may have met criteria for both BSI and SSI (deep incisional or organ/space).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3450 participants
• Primary outcome timeframe: Day of surgery (Day 1) up to Day 90
• Results posted on: 2021-01-05

Participant Flow

Participant milestones

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) Participants randomized to SA4Ag received a single dose of 0.5 milliliter (mL) SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Study STARTED	1726	1724
Overall Study Vaccinated (Safety Population)	1708	1709
Overall Study COMPLETED	1599	1594
Overall Study NOT COMPLETED	127	130

Reasons for withdrawal

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) Participants randomized to SA4Ag received a single dose of 0.5 milliliter (mL) SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Overall Study Study terminated by sponsor	5	5
Overall Study Other	11	13
Overall Study No longer meet eligibility criteria	40	43
Overall Study Withdrawal of consent	31	32
Overall Study Lost to Follow-up	19	20
Overall Study Death	13	10
Overall Study Adverse Event	3	5
Overall Study Did not meet entrance criteria	5	2

Baseline Characteristics

Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation

Baseline characteristics by cohort

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1708 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1709 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Total n=3417 Participants Total of all reporting groups
Age, Continuous	62.7 Years STANDARD_DEVIATION 12.3 • n=5 Participants	62.6 Years STANDARD_DEVIATION 12.6 • n=7 Participants	62.7 Years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	950 Participants n=5 Participants	940 Participants n=7 Participants	1890 Participants n=5 Participants
Sex: Female, Male Male	758 Participants n=5 Participants	769 Participants n=7 Participants	1527 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	69 Participants n=5 Participants	69 Participants n=7 Participants	138 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1634 Participants n=5 Participants	1639 Participants n=7 Participants	3273 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	295 Participants n=5 Participants	290 Participants n=7 Participants	585 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	90 Participants n=5 Participants	111 Participants n=7 Participants	201 Participants n=5 Participants
Race (NIH/OMB) White	1295 Participants n=5 Participants	1283 Participants n=7 Participants	2578 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of surgery (Day 1) up to Day 90

Population: Per-protocol (PP) efficacy population: all eligible participants, vaccinated as randomized, who underwent surgery per study-defined criteria within 9-90 days (inclusive) post vaccination (expanded from 10-60 days window in protocol), had no infection/malignancy at surgery and had no major protocol violation prior to reporting S. aureus infection.

BSI: clinical infection involved a recognized pathogen (S. aureus) cultured from 1 or more blood cultures or a commensal organism cultured from 2 or more blood cultures whether primary or secondary to infection at another site. SSI: infection at a surgical incision. Types of SSI in this outcome measure: Deep incisional SSI: infection involved deep soft tissues of incision (example [e.g.] fascial and muscle layers), Organ/space SSI: infection involved any part of body excluding skin incision, fascia or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative BSI and/or SSI (including deep incisional or organ/space), caused by S. aureus, occurred within 90 days of post elective open posterior spinal fusion surgery with multilevel instrumentation, as confirmed by event adjudication committee (EAC) have been reported. A participant may have met criteria for both BSI and SSI (deep incisional or organ/space).

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1544 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1547 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Number of Participants With Postoperative Staphylococcus (S.) Aureus Bloodstream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 90 Days After Spinal Surgery	14 Participants	14 Participants

PRIMARY outcome

Timeframe: Within 10 days after Vaccination

Population: Safety population: all participants who received investigational product in this study. Here, "Overall Number of Participants Analyzed, N" signifies number of participants analyzed for this outcome measure.

Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were categorized as mild (2.5 to 5.0 centimeters [cm]), moderate (5.5 to 10.0 cm) and, severe (greater than or equal to [>=] 10.5 cm). Pain at the injection site was defined as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling, pain at the injection site represents any grade of these local reactions among mild, moderate or severe.

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1692 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1685 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Redness: Any	9.2 Percentage of participants Interval 7.9 to 10.7	0.9 Percentage of participants Interval 0.5 to 1.5
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Redness: Mild	5.3 Percentage of participants Interval 4.2 to 6.4	0.9 Percentage of participants Interval 0.5 to 1.5
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Redness: Moderate	3.1 Percentage of participants Interval 2.4 to 4.1	0.1 Percentage of participants Interval 0.0 to 0.3
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Redness: Severe	0.8 Percentage of participants Interval 0.5 to 1.4	0.0 Percentage of participants Interval 0.0 to 0.2
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Swelling: Any	8.0 Percentage of participants Interval 6.7 to 9.4	1.0 Percentage of participants Interval 0.6 to 1.6
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Swelling: Mild	4.6 Percentage of participants Interval 3.6 to 5.7	0.7 Percentage of participants Interval 0.4 to 1.2
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Swelling: Moderate	2.7 Percentage of participants Interval 2.0 to 3.6	0.3 Percentage of participants Interval 0.1 to 0.7
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Swelling: Severe	0.7 Percentage of participants Interval 0.4 to 1.2	0.0 Percentage of participants Interval 0.0 to 0.2
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Pain at the injection site: Any	24.1 Percentage of participants Interval 22.1 to 26.2	8.4 Percentage of participants Interval 7.1 to 9.9
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Pain at the injection site: Mild	19.2 Percentage of participants Interval 17.4 to 21.2	7.0 Percentage of participants Interval 5.8 to 8.3
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Pain at the injection site: Moderate	4.3 Percentage of participants Interval 3.4 to 5.4	1.3 Percentage of participants Interval 0.8 to 2.0
Percentage of Participants With Local Reactions Within 10 Days After Vaccination Pain at the injection site: Severe	0.6 Percentage of participants Interval 0.3 to 1.1	0.1 Percentage of participants Interval 0.0 to 0.4

PRIMARY outcome

Timeframe: Within 10 days after Vaccination

Population: Safety population: all participants who received investigational product in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants analyzed for this outcome measure.

Systemic reactions included fever, fatigue, headache, diarrhea, vomiting, muscle pain and joint pain, were recorded using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and greater than (>) 40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Participants may be represented in more than 1 row. Here "any" for fever, fatigue, headache, vomiting, diarrhea, muscle pain, joint pain represents any grade of these systemic reactions among mild, moderate or severe.

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1692 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1685 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Fever: Any	2.0 Percentage of participants Interval 1.4 to 2.8	1.4 Percentage of participants Interval 0.9 to 2.0
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Fever: 38.0 degree C to 38.4 degree C	1.3 Percentage of participants Interval 0.8 to 2.0	0.9 Percentage of participants Interval 0.5 to 1.5
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Fever: 38.5 degree C to 38.9 degree C	0.5 Percentage of participants Interval 0.2 to 0.9	0.4 Percentage of participants Interval 0.2 to 0.9
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Fever: 39.0 degree C to 40.0 degree C	0.2 Percentage of participants Interval 0.0 to 0.5	0.1 Percentage of participants Interval 0.0 to 0.3
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Fever: >40.0 degree C	0.1 Percentage of participants Interval 0.0 to 0.3	0.0 Percentage of participants Interval 0.0 to 0.2
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Fatigue: Any	43.3 Percentage of participants Interval 40.9 to 45.7	40.4 Percentage of participants Interval 38.1 to 42.8
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Fatigue: Mild	14.0 Percentage of participants Interval 12.4 to 15.8	12.6 Percentage of participants Interval 11.1 to 14.3
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Fatigue: Moderate	24.9 Percentage of participants Interval 22.8 to 27.0	23.6 Percentage of participants Interval 21.6 to 25.7
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Fatigue: Severe	4.4 Percentage of participants Interval 3.4 to 5.5	4.2 Percentage of participants Interval 3.3 to 5.2
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Headache: Any	32.4 Percentage of participants Interval 30.2 to 34.7	31.2 Percentage of participants Interval 29.0 to 33.5
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Headache: Mild	17.7 Percentage of participants Interval 15.9 to 19.6	18.0 Percentage of participants Interval 16.2 to 19.9
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Headache: Moderate	13.5 Percentage of participants Interval 11.9 to 15.3	12.0 Percentage of participants Interval 10.5 to 13.6
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Headache: Severe	1.2 Percentage of participants Interval 0.8 to 1.9	1.2 Percentage of participants Interval 0.8 to 1.9
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Diarrhea: Any	17.0 Percentage of participants Interval 15.2 to 18.8	16.0 Percentage of participants Interval 14.3 to 17.9
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Diarrhea: Mild	13.0 Percentage of participants Interval 11.4 to 14.7	12.2 Percentage of participants Interval 10.7 to 13.9
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Diarrhea: Moderate	3.4 Percentage of participants Interval 2.6 to 4.4	2.9 Percentage of participants Interval 2.2 to 3.8
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Diarrhea: Severe	0.5 Percentage of participants Interval 0.2 to 1.0	0.9 Percentage of participants Interval 0.5 to 1.5
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Vomiting: Any	2.7 Percentage of participants Interval 1.9 to 3.5	3.3 Percentage of participants Interval 2.5 to 4.2
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Vomiting: Mild	2.4 Percentage of participants Interval 1.7 to 3.2	2.6 Percentage of participants Interval 1.9 to 3.5
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Vomiting: Moderate	0.3 Percentage of participants Interval 0.1 to 0.7	0.7 Percentage of participants Interval 0.3 to 1.2
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Vomiting: Severe	0.0 Percentage of participants Interval 0.0 to 0.2	0.0 Percentage of participants Interval 0.0 to 0.2
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Muscle pain: Any	27.9 Percentage of participants Interval 25.8 to 30.1	26.2 Percentage of participants Interval 24.1 to 28.4
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Muscle pain: Mild	10.1 Percentage of participants Interval 8.7 to 11.6	9.3 Percentage of participants Interval 8.0 to 10.8
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Muscle pain: Moderate	15.7 Percentage of participants Interval 14.0 to 17.5	14.6 Percentage of participants Interval 12.9 to 16.4
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Muscle pain: Severe	2.1 Percentage of participants Interval 1.5 to 2.9	2.3 Percentage of participants Interval 1.7 to 3.2
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Joint pain: Any	27.5 Percentage of participants Interval 25.4 to 29.7	25.8 Percentage of participants Interval 23.7 to 28.0
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Joint pain: Mild	9.6 Percentage of participants Interval 8.3 to 11.1	8.0 Percentage of participants Interval 6.7 to 9.3
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Joint pain: Moderate	16.1 Percentage of participants Interval 14.4 to 17.9	16.1 Percentage of participants Interval 14.4 to 18.0
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination Joint pain: Severe	1.8 Percentage of participants Interval 1.2 to 2.5	1.7 Percentage of participants Interval 1.2 to 2.5

PRIMARY outcome

Timeframe: From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)

Population: Safety population: all participants who received investigational product in this study.

An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs.

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1708 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1709 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Number of Participants With Adverse Events (AEs) From Vaccination Until The Day of Surgery (Day 1)	213 Participants	178 Participants

PRIMARY outcome

Timeframe: From vaccination until Day 42 after surgery (52-102 days after vaccination)

Population: Safety population: all participants who received investigational product in this study.

An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs.

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1708 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1709 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Number of Participants With Adverse Events (AEs) From Vaccination Until First Postoperative Evaluation on Day 42	1198 Participants	1213 Participants

PRIMARY outcome

Timeframe: Day of surgery (Day 1) up to Day 42 after surgery

Population: Safety population: all participants who received investigational product in this study.

An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs.

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1708 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1709 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Number of Participants With Adverse Events (AEs) From The Day of Surgery (Day 1) Until First Postoperative Evaluation on Day 42	1136 Participants	1167 Participants

PRIMARY outcome

Timeframe: Day 42 up to Day 180 (up to 138 days)

Population: Safety population: all participants who received investigational product in this study.

A newly diagnosed chronic medical disorder was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1708 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1709 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Number of Participants With Newly Diagnosed Chronic Medical Disorders From First Postoperative Evaluation on Day 42 Until Last Postoperative Evaluation on Day 180	29 Participants	41 Participants

PRIMARY outcome

Timeframe: From vaccination up to Day 180 after surgery (190-240 days after vaccination)

Population: Safety population: all participants who received investigational product in this study.

An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly.

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1708 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1709 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Last Postoperative Evaluation on Day 180	403 Participants	424 Participants

PRIMARY outcome

Timeframe: From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)

Population: Safety population: all participants who received investigational product in this study.

An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly.

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1708 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1709 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1)	27 Participants	26 Participants

PRIMARY outcome

Timeframe: Day of surgery (Day 1) up to Day 180 after surgery

Population: Safety population: all participants who received investigational product in this study.

An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly.

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1708 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1709 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Number of Participants With Serious Adverse Events (SAEs) From The Day of Surgery (Day 1) Until Last Postoperative Evaluation on Day 180	384 Participants	401 Participants

SECONDARY outcome

Timeframe: Day of surgery (Day 1) up to Day 180 after surgery

Population: PP efficacy population: all eligible participants, vaccinated as randomized, who underwent surgery per study-defined criteria within 9-90 days (inclusive) post vaccination (expanded from 10-60 days window in protocol), had no infection/malignancy at surgery and had no major protocol violation prior to reporting S. aureus infection.

BSI: clinical infection involved a recognized pathogen (S. aureus) cultured from 1 or more blood cultures or a commensal organism cultured from 2 or more blood cultures whether primary or secondary to infection at another site. SSI: infection at a surgical incision. Types of SSI in this outcome measure: Deep incisional SSI: infection involved deep soft tissues of incision (e.g. fascial and muscle layers), Organ/space SSI: infection involved any part of body excluding skin incision, fascia or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative BSI and/or SSI (including deep incisional or organ/space), caused by S. aureus, occurred within 180 days of post elective open posterior spinal fusion surgery with multilevel instrumentation, as confirmed by EAC have been reported. A participant may have met criteria for both BSI and SSI (deep incisional or organ/space).

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1544 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1547 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Number of Participants With Postoperative S. Aureus Blood Stream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery	14 Participants	14 Participants

SECONDARY outcome

Timeframe: Day of surgery (Day 1) up to Day 90 after surgery

Population: PP efficacy population: all eligible participants, vaccinated as randomized, who underwent surgery per study-defined criteria within 9-90 days (inclusive) post vaccination (expanded from 10-60 days window in protocol), had no infection/malignancy at surgery and had no major protocol violation prior to reporting S. aureus infection.

SSI: infection at a surgical incision. Types of SSI in this outcome measure: Superficial SSI: Infection involved only skin and subcutaneous tissue of the incision, Deep incisional SSI: infection involved deep soft tissues of incision (e.g. fascial and muscle layers), Organ/space SSI: infection involved any part of body, excluding skin incision, fascia, or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative SSI (including superficial, deep incisional and/or organ/space SSI) caused by S. aureus, occurred within 90 days after elective open posterior spinal fusion surgery with multilevel instrumentation as confirmed by EAC have been reported.

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1544 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1547 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 90 Days After Surgery	24 Participants	22 Participants

SECONDARY outcome

Timeframe: Day of surgery (Day 1) up to Day 180 after surgery

Population: PP efficacy population: all eligible participants, vaccinated as randomized, who underwent surgery per study-defined criteria within 9-90 days (inclusive) post vaccination (expanded from 10-60 days window in protocol), had no infection/malignancy at surgery and had no major protocol violation prior to reporting S. aureus infection.

SSI: infection at a surgical incision. Types of SSI in this outcome measure: Superficial SSI: Infection involved only skin and subcutaneous tissue of the incision, Deep incisional SSI: infection involved deep soft tissues of incision (e.g. fascial and muscle layers), Organ/space SSI: infection involved any part of body, excluding skin incision, fascia, or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative SSI (including superficial, deep incisional and/or organ/space SSI) caused by S. aureus, occurred within 180 days after elective open posterior spinal fusion surgery with multilevel instrumentation as confirmed by EAC have been reported.

Outcome measures

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1544 Participants Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1547 Participants Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery	25 Participants	23 Participants

Adverse Events

Staphylococcus Aureus 4-antigen (SA4Ag)

Serious events: 403 serious events

Other events: 1530 other events

Deaths: 13 deaths

Placebo

Serious events: 424 serious events

Other events: 1489 other events

Deaths: 10 deaths

Serious adverse events

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1708 participants at risk Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1709 participants at risk Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Gastrointestinal disorders Large intestine polyp	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Anaemia	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Normocytic anaemia	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Platelet disorder	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Thrombocytopenia	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Acute coronary syndrome	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Acute myocardial infarction	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Acute right ventricular failure	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Angina pectoris	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Angina unstable	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Arteriospasm coronary	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Atrial fibrillation	0.70% 12/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.59% 10/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Atrial flutter	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Bradycardia	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Cardiac arrest	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Cardiac failure	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Cardiac failure acute	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Cardiac failure chronic	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Cardiac failure congestive	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Cardiogenic shock	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Coronary artery disease	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Coronary artery occlusion	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Coronary artery stenosis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Left ventricular dysfunction	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Myocardial infarction	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Sinus node dysfunction	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Sinus tachycardia	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Supraventricular tachycardia	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Tachycardia	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Ventricular tachycardia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Congenital, familial and genetic disorders Spinal muscular atrophy	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Ear and labyrinth disorders Vertigo positional	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Eye disorders Blindness unilateral	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Eye disorders Cataract	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Eye disorders Retinal detachment	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Abdominal pain	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Abdominal pain upper	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Anal incontinence	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Anorectal disorder	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Colitis	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Constipation	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Diarrhoea	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Diverticulum	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Duodenal ulcer	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Dysphagia	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Gastritis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Gastrointestinal ulcer	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Ileus	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.29% 5/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Inguinal hernia	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Intestinal obstruction	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Large intestine perforation	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Melaena	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Nausea	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Obstruction gastric	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Pancreatitis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Pancreatitis acute	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Pneumoperitoneum	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Proctitis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Rectal prolapse	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Retroperitoneal haematoma	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Small intestinal obstruction	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Subileus	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Vomiting	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Asthenia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Calcinosis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Chest pain	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.29% 5/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Complication associated with device	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Complication of device insertion	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Dysplasia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Fatigue	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Fibrosis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Gait disturbance	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Hernia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Impaired healing	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Medical device site reaction	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Multiple organ dysfunction syndrome	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Pain	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Peripheral swelling	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Pyrexia	0.35% 6/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.41% 7/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Surgical failure	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Hepatobiliary disorders Bile duct stone	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Hepatobiliary disorders Cholecystitis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Hepatobiliary disorders Cholecystitis acute	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Hepatobiliary disorders Cholelithiasis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Abdominal distension	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Immune system disorders Anaphylactic reaction	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Immune system disorders Anaphylactic shock	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Immune system disorders Drug hypersensitivity	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Abscess jaw	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Abscess limb	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Atypical pneumonia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Bacteraemia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Bacterial disease carrier	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Bronchitis	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Cellulitis	0.29% 5/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Clostridium colitis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Clostridium difficile colitis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Clostridium difficile infection	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Cystitis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Device related infection	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Diverticulitis	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Encephalitis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Enterobacter bacteraemia	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Escherichia bacteraemia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Escherichia urinary tract infection	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Extradural abscess	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Fournier's gangrene	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Gastroenteritis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Herpes zoster	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Incision site abscess	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Infected skin ulcer	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Influenza	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Intervertebral discitis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Lice infestation	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Lymphangitis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Medical device site joint infection	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Meningitis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Osteomyelitis	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Osteomyelitis chronic	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Perirectal abscess	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Pneumonia	1.1% 19/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.70% 12/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Pneumonia bacterial	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Post procedural infection	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Postoperative wound infection	1.6% 27/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.9% 32/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Pyelonephritis	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Pyelonephritis acute	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Sepsis	0.64% 11/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.59% 10/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Septic shock	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Skin infection	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Staphylococcal infection	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Upper respiratory tract infection	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Urinary tract infection	0.35% 6/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.41% 7/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Urosepsis	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Viral infection	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Wound infection	0.29% 5/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.29% 5/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Wound infection bacterial	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Wound infection fungal	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Wound infection staphylococcal	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Adjacent segment degeneration	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Anaemia postoperative	0.47% 8/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Aortic injury	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Cardiac function disturbance postoperative	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Concussion	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Contusion	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Cystitis radiation	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Device deployment issue	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Device dispensing error	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Dural tear	0.53% 9/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.53% 9/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Endotracheal intubation complication	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Exposure to communicable disease	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Extradural haematoma	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Fall	0.53% 9/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Femoral neck fracture	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Femur fracture	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Flatback syndrome	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Foreign body	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Fracture	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Fractured sacrum	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Graft complication	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Heart injury	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Humerus fracture	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Incision site haematoma	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Incomplete spinal fusion	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Joint dislocation	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.35% 6/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.29% 5/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Multiple fractures	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Multiple injuries	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Muscle strain	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Overdose	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Post laminectomy syndrome	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Post procedural constipation	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Post procedural discharge	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Post procedural fever	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Post procedural haematoma	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.41% 7/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Postoperative delirium	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Postoperative ileus	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.41% 7/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Procedural complication	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Procedural haemorrhage	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Procedural hypotension	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Procedural pain	0.41% 7/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.53% 9/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Pseudomeningocele	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Seroma	0.35% 6/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Spinal column injury	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Spinal compression fracture	0.35% 6/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Spinal cord injury cauda equina	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Spinal fracture	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Subdural haematoma	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Subdural haemorrhage	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Suture rupture	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Toxicity to various agents	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Urethral injury	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Vascular injury	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Venous injury	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Wound dehiscence	0.29% 5/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Wound secretion	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Investigations Blood glucose increased	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Investigations Electrocardiogram abnormal	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Investigations Haemoglobin decreased	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Investigations Hepatic enzyme increased	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Investigations Oxygen saturation decreased	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Investigations Troponin increased	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Dehydration	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Failure to thrive	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Fluid overload	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Gout	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Hyperkalaemia	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Hypoglycaemia	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Hyponatraemia	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Hypovolaemia	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Arthritis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Back pain	0.47% 8/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.41% 7/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Foot deformity	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Kyphosis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Mobility decreased	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Muscle spasms	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Muscular weakness	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Myopathy	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.70% 12/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Pain in extremity	0.41% 7/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Polymyositis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Scoliosis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Spinal deformity	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Spinal disorder	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Spinal instability	0.29% 5/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Spinal ligament ossification	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Spinal segmental dysfunction	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of ampulla of vater	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mediastinum neoplasm	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloid leukaemia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal meningioma benign	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Cauda equina syndrome	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Cerebral haemorrhage	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Cerebral infarction	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Cerebrospinal fistula	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Cerebrospinal fluid leakage	0.29% 5/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.29% 5/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Cerebrovascular accident	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Cervical radiculopathy	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Cervical spinal cord paralysis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Decreased vibratory sense	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Dizziness	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Dysarthria	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Encephalopathy	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.29% 5/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Facial paralysis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Generalised tonic-clonic seizure	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Headache	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Hemiparesis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Hepatic encephalopathy	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders IIIrd nerve paresis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Ischaemic stroke	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Loss of consciousness	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Lumbar radiculopathy	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Metabolic encephalopathy	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Miller Fisher syndrome	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Monoparesis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Monoplegia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Myelopathy	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Neuropathy peripheral	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Normal pressure hydrocephalus	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Paraesthesia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Paralysis	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Paraparesis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Paraplegia	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Parkinson's disease	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Polyneuropathy	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Presyncope	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Radiculopathy	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Sciatica	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Sedation	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Seizure	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Spinal cord compression	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Spinal cord disorder	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Spinal epidural haematoma	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Syncope	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.29% 5/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Thalamus haemorrhage	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Thrombotic cerebral infarction	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Transient ischaemic attack	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Trigeminal neuralgia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Visual field defect	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Vocal cord paralysis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Product Issues Device breakage	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Product Issues Device dislocation	0.64% 11/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.35% 6/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Product Issues Device failure	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.35% 6/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Product Issues Device fastener issue	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Product Issues Device loosening	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Product Issues Implant subsidence	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Psychiatric disorders Alcohol withdrawal syndrome	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Psychiatric disorders Anxiety	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Psychiatric disorders Confusional state	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Psychiatric disorders Delirium	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Psychiatric disorders Delirium tremens	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Psychiatric disorders Mental disorder	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Psychiatric disorders Mental status changes	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.41% 7/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Psychiatric disorders Suicidal ideation	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Acute kidney injury	0.35% 6/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.47% 8/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Bladder disorder	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Bladder neck obstruction	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Chronic kidney disease	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Dysuria	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Haematuria	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Nephrolithiasis	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Nephropathy	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Neurogenic bladder	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Renal failure	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Renal injury	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Ureterolithiasis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Urethral stenosis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Urinary incontinence	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Urinary retention	0.23% 4/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Reproductive system and breast disorders Prostatic haemorrhage	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.41% 7/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Aspiration	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Asthma	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Eosinophilic pneumonia	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.23% 4/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Pharyngeal ulceration	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.3% 22/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.99% 17/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.41% 7/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Respiratory tract oedema	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Skin and subcutaneous tissue disorders Skin ulcer	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.12% 2/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Surgical and medical procedures Arthrodesis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Surgical and medical procedures Muscle flap operation	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Surgical and medical procedures Spinal fusion surgery	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Deep vein thrombosis	1.2% 21/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.1% 19/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Haematoma	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Haemodynamic instability	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Haemorrhage	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Hypertension	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Hypotension	0.76% 13/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.59% 10/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Hypovolaemic shock	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.18% 3/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Iliac artery occlusion	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Intermittent claudication	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Ischaemia	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Labile blood pressure	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Orthostatic hypotension	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Pelvic venous thrombosis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Peripheral artery thrombosis	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Peripheral ischaemia	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Shock	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Shock haemorrhagic	0.18% 3/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Subclavian vein thrombosis	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Thrombophlebitis superficial	0.12% 2/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Venous thrombosis limb	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Lower limb fracture	0.06% 1/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.00% 0/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Uncoded System Organ Class	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Meningoencephalitis septic shock	0.00% 0/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.06% 1/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.

Other adverse events

Measure	Staphylococcus Aureus 4-antigen (SA4Ag) n=1708 participants at risk Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.	Placebo n=1709 participants at risk Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure.
Blood and lymphatic system disorders Anaemia	5.7% 97/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	7.1% 122/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Blood loss anaemia	3.4% 58/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	2.5% 42/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Leukocytosis	1.1% 18/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.2% 20/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Blood and lymphatic system disorders Thrombocytopenia	1.5% 26/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.3% 23/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Cardiac disorders Tachycardia	1.9% 32/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.8% 30/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Constipation	11.8% 201/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	11.2% 192/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Diarrhoea 1	1.8% 31/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.8% 30/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Nausea	9.5% 162/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	8.2% 140/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Vomiting 1	4.7% 80/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	3.9% 67/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Chest pain	1.1% 18/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.76% 13/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Oedema peripheral	1.3% 22/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.7% 29/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Pyrexia 1	7.1% 121/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	6.7% 114/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Nasopharyngitis	1.6% 28/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.3% 23/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Infections and infestations Urinary tract infection	5.6% 96/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	6.0% 103/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Anaemia postoperative	6.4% 109/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	6.3% 108/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Dural tear	3.5% 60/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	4.3% 73/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Fall	3.5% 60/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	2.6% 44/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Incision site pain	3.9% 67/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	3.7% 63/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Procedural pain	5.4% 92/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	4.9% 84/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Injury, poisoning and procedural complications Wound complication	1.1% 19/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.2% 21/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Hyperglycaemia	1.6% 28/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.5% 25/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Hypokalaemia	1.4% 24/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.1% 18/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Metabolism and nutrition disorders Hyponatraemia	1.3% 22/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.2% 20/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Arthralgia 1	1.6% 27/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.7% 29/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Back pain	2.3% 39/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	2.1% 36/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Muscle spasms	1.2% 21/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.8% 30/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Muscular weakness	1.5% 25/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.4% 24/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.4% 24/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.2% 20/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 55/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	3.5% 59/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Dizziness	1.8% 30/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	2.0% 35/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Headache 1	1.9% 33/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.5% 26/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Hypoaesthesia	2.9% 50/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	2.2% 38/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Paraesthesia	1.4% 24/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.70% 12/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Psychiatric disorders Insomnia	4.0% 68/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	3.7% 63/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Acute kidney injury	1.4% 24/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.76% 13/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Renal and urinary disorders Urinary retention	3.4% 58/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	3.5% 59/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.59% 10/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.2% 21/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Cough	0.47% 8/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.1% 19/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.4% 24/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	2.0% 35/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Skin and subcutaneous tissue disorders Erythema	3.3% 57/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	3.6% 61/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Skin and subcutaneous tissue disorders Pruritus	1.6% 27/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.9% 33/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Skin and subcutaneous tissue disorders Rash	1.2% 21/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.88% 15/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Hypertension	0.88% 15/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.2% 20/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Vascular disorders Hypotension	4.6% 79/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	4.9% 84/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Diarrhoea 2	16.8% 287/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	15.8% 270/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Gastrointestinal disorders Vomiting 2	2.6% 45/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	3.2% 55/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Fatigue	42.9% 732/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	39.8% 681/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Injection site erythema	9.1% 156/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.94% 16/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Injection site pain	23.9% 408/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	8.3% 142/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Injection site swelling	7.9% 135/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	0.99% 17/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
General disorders Pyrexia 2	2.0% 34/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	1.3% 23/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Arthralgia 2	27.2% 465/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	25.5% 435/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Musculoskeletal and connective tissue disorders Myalgia (muscle pain)	27.6% 472/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	25.9% 442/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.
Nervous system disorders Headache 2	32.1% 549/1708 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.	30.8% 526/1709 • SAE and non-SAE: From vaccination up to Day 180 (190-240 days after vaccination). Local and systemic reactions: within 10 days after vaccination (systematic assessment). Safety population: included all participants who had received investigational product in this study. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the analysis population.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER