Trial Outcomes & Findings for Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012) (NCT NCT02503202)

NCT ID: NCT02503202

Last Updated: 2018-10-12

Results Overview

Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1197 participants
• Primary outcome timeframe: Day 28 postvaccination
• Results posted on: 2018-10-12

Participant Flow

A total of 1261 participants were screened and 1197 were randomized.

Participant milestones

Measure	V920 Consistency Lot A Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Base Study: Up to Month 6 STARTED	266	265	267	266	133
Base Study: Up to Month 6 Vaccinated	266	265	266	264	133
Base Study: Up to Month 6 COMPLETED	248	253	252	255	130
Base Study: Up to Month 6 NOT COMPLETED	18	12	15	11	3
Extension: Month 6 to 24 STARTED	119	130	112	137	68
Extension: Month 6 to 24 COMPLETED	108	114	103	119	67
Extension: Month 6 to 24 NOT COMPLETED	11	16	9	18	1

Reasons for withdrawal

Measure	V920 Consistency Lot A Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Base Study: Up to Month 6 Death	1	1	0	0	0
Base Study: Up to Month 6 Lost to Follow-up	11	8	10	5	1
Base Study: Up to Month 6 Physician Decision	0	0	0	0	1
Base Study: Up to Month 6 Withdrawal by Subject	6	3	4	4	1
Base Study: Up to Month 6 Randomized not vaccinated	0	0	1	2	0
Extension: Month 6 to 24 Protocol Violation	0	0	0	1	0
Extension: Month 6 to 24 Death	1	0	0	0	0
Extension: Month 6 to 24 Lost to Follow-up	4	8	6	10	1
Extension: Month 6 to 24 Physician Decision	1	0	1	3	0
Extension: Month 6 to 24 Withdrawal by Subject	5	8	2	4	0

Baseline Characteristics

Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)

Baseline characteristics by cohort

Measure	V920 Consistency Lot A n=266 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B n=265 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C n=267 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot n=266 Participants Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo n=133 Participants Participants received a 1.0-mL intramuscular injection of placebo on Day 1	Total n=1197 Participants Total of all reporting groups
Age, Continuous	41.3 Years STANDARD_DEVIATION 13.4 • n=5 Participants	41.5 Years STANDARD_DEVIATION 12.4 • n=7 Participants	40.9 Years STANDARD_DEVIATION 13.1 • n=5 Participants	41.7 Years STANDARD_DEVIATION 13.4 • n=4 Participants	41.1 Years STANDARD_DEVIATION 13.7 • n=21 Participants	41.3 Years STANDARD_DEVIATION 13.1 • n=8 Participants
Sex: Female, Male Female	143 Participants n=5 Participants	135 Participants n=7 Participants	138 Participants n=5 Participants	149 Participants n=4 Participants	72 Participants n=21 Participants	637 Participants n=8 Participants
Sex: Female, Male Male	123 Participants n=5 Participants	130 Participants n=7 Participants	129 Participants n=5 Participants	117 Participants n=4 Participants	61 Participants n=21 Participants	560 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 28 postvaccination

Population: Participants who were compliant with the protocol, received vaccination, were seronegative at Day 1, and had a serum sample collected within the acceptable day range

Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL.

Outcome measures

Measure	V920 Consistency Lot A n=239 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B n=231 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C n=226 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot n=219 Participants Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo n=124 Participants Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody	1183.9 EU/mL Interval 1038.7 to 1349.4	1266.0 EU/mL Interval 1108.2 to 1446.2	1346.0 EU/mL Interval 1176.6 to 1539.9	1291.9 EU/mL Interval 1126.9 to 1481.2	NA EU/mL Geometric Mean and CIs are \<36.11 EU/mL

PRIMARY outcome

Timeframe: Up to Month 6 postvaccination

Population: Randomized participants who received vaccination and had follow-up data for the outcome measure

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose.

Outcome measures

Measure	V920 Consistency Lot A n=265 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot n=260 Participants Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo n=133 Participants Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Percentage of Participants Reporting Serious Adverse Events	2.6 Percentage of participants	1.5 Percentage of participants	2.7 Percentage of participants	1.2 Percentage of participants	0.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to Day 5 postvaccination

Population: Randomized participants who received vaccination and had follow-up data for the outcome measure

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling.

Outcome measures

Measure	V920 Consistency Lot A n=265 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot n=260 Participants Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo n=133 Participants Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card Injection-site erythema	14.7 Percentage of participants	10.6 Percentage of participants	14.8 Percentage of participants	7.3 Percentage of participants	1.5 Percentage of participants
Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card Injection-site pain	66.8 Percentage of participants	73.0 Percentage of participants	70.3 Percentage of participants	67.7 Percentage of participants	12.8 Percentage of participants
Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card Injection-site swelling	17.7 Percentage of participants	13.7 Percentage of participants	18.3 Percentage of participants	16.2 Percentage of participants	3.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to Day 42 postvaccination

Population: Randomized participants who received vaccination and had follow-up data for the outcome measure

Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42. Elevated temperature was defined as ≥38.0° C (≥100.4° F).

Outcome measures

Measure	V920 Consistency Lot A n=262 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot n=258 Participants Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo n=132 Participants Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Percentage of Participants With Elevated Maximum Temperature	21.4 Percentage of participants	16.7 Percentage of participants	22.4 Percentage of participants	32.2 Percentage of participants	0.8 Percentage of participants

PRIMARY outcome

Timeframe: From Day 5 to Day 42 postvaccination

Population: Randomized participants who received vaccination and had follow-up data for the outcome measure

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Adverse events of arthralgia and arthritis were prompted on the VRC.

Outcome measures

Measure	V920 Consistency Lot A n=265 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot n=260 Participants Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo n=133 Participants Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card Arthralgia AEs	5.7 Percentage of participants	5.7 Percentage of participants	6.5 Percentage of participants	7.7 Percentage of participants	1.5 Percentage of participants
Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card Arthritis AEs	4.5 Percentage of participants	3.8 Percentage of participants	2.7 Percentage of participants	3.1 Percentage of participants	0.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to Day 42 postvaccination

Population: Randomized participants who received vaccination and had follow-up data for the outcome measure

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash.

Outcome measures

Measure	V920 Consistency Lot A n=265 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot n=260 Participants Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo n=133 Participants Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card	3.0 Percentage of participants	4.6 Percentage of participants	3.8 Percentage of participants	3.8 Percentage of participants	1.5 Percentage of participants

PRIMARY outcome

Timeframe: Up to Day 42 postvaccination

Population: Randomized participants who received vaccination and had follow-up data for the outcome measure

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Vesicular lesion AEs prompted on the VRC included blister and rash vesicular.

Outcome measures

Measure	V920 Consistency Lot A n=265 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C n=263 Participants Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot n=260 Participants Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo n=133 Participants Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card	1.9 Percentage of participants	1.1 Percentage of participants	1.5 Percentage of participants	1.5 Percentage of participants	0.0 Percentage of participants

Adverse Events

V920 Consistency Lot A

Serious events: 12 serious events

Other events: 211 other events

Deaths: 2 deaths

V920 Consistency Lot B

Serious events: 12 serious events

Other events: 211 other events

Deaths: 1 deaths

V920 Consistency Lot C

Serious events: 11 serious events

Other events: 208 other events

Deaths: 0 deaths

V920 High-dose Lot

Serious events: 8 serious events

Other events: 208 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	V920 Consistency Lot A n=265 participants at risk Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B n=263 participants at risk Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C n=263 participants at risk Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot n=260 participants at risk Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo n=133 participants at risk Participants received a 1.0-mL intramuscular injection of placebo on Day 1
Ear and labyrinth disorders Conductive deafness	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Endocrine disorders Hyperthyroidism	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Gastrointestinal disorders Abdominal incarcerated hernia	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Gastrointestinal disorders Abdominal pain	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Gastrointestinal disorders Gastrointestinal disorder	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/260 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Hepatobiliary disorders Cholecystitis	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Hepatobiliary disorders Hepatic failure	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Infections and infestations Appendicitis	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Infections and infestations Cellulitis	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Infections and infestations Clostridium difficile infection	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Infections and infestations Diverticulitis	0.38% 1/265 • Number of events 2 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Infections and infestations Mastitis	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Infections and infestations Meningitis aseptic	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Infections and infestations Pneumonia	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Infections and infestations Upper respiratory tract infection	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Infections and infestations Urinary tract infection	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Animal bite	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Craniocerebral injury	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/260 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Rib fracture	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Road traffic accident	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Injury, poisoning and procedural complications Scapula fracture	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Investigations Platelet count decreased	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Exostosis	0.38% 1/265 • Number of events 2 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/260 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/260 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage III	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal squamous cell carcinoma	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Nervous system disorders Migraine	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Nervous system disorders Radicular pain	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/260 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Pregnancy, puerperium and perinatal conditions Ruptured ectopic pregnancy	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/260 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Psychiatric disorders Schizophrenia	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/260 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Psychiatric disorders Suicidal ideation	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/260 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Renal and urinary disorders Nephrolithiasis	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Renal and urinary disorders Renal failure	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/265 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.38% 1/263 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Vascular disorders Deep vein thrombosis	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Vascular disorders Hypertension	0.38% 1/265 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/263 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/260 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.00% 0/133 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.

Other adverse events

Measure	V920 Consistency Lot A n=265 participants at risk Participants received a 1.0-mL intramuscular injection of V920 consistency Lot A on Day 1	V920 Consistency Lot B n=263 participants at risk Participants received a 1.0-mL intramuscular injection of V920 consistency Lot B on Day 1	V920 Consistency Lot C n=263 participants at risk Participants received a 1.0-mL intramuscular injection of V920 consistency Lot C on Day 1	V920 High-dose Lot n=260 participants at risk Participants received a 1.0-mL intramuscular injection of V920 high-dose lot on Day 1	Placebo n=133 participants at risk Participants received a 1.0-mL intramuscular injection of placebo on Day 1
General disorders Pyrexia	21.9% 58/265 • Number of events 66 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	17.9% 47/263 • Number of events 47 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	24.0% 63/263 • Number of events 70 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	29.2% 76/260 • Number of events 83 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 4 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Arthralgia	17.7% 47/265 • Number of events 72 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	15.6% 41/263 • Number of events 74 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	19.0% 50/263 • Number of events 75 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	20.4% 53/260 • Number of events 79 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	3.0% 4/133 • Number of events 7 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Musculoskeletal and connective tissue disorders Myalgia	6.4% 17/265 • Number of events 19 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	4.2% 11/263 • Number of events 13 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	4.6% 12/263 • Number of events 12 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	8.8% 23/260 • Number of events 23 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Nervous system disorders Headache	23.0% 61/265 • Number of events 72 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	19.4% 51/263 • Number of events 56 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	20.9% 55/263 • Number of events 68 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	25.8% 67/260 • Number of events 83 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	11.3% 15/133 • Number of events 18 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
Gastrointestinal disorders Nausea	4.5% 12/265 • Number of events 12 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	4.9% 13/263 • Number of events 13 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	5.7% 15/263 • Number of events 16 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	5.4% 14/260 • Number of events 15 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
General disorders Chills	5.3% 14/265 • Number of events 14 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	6.1% 16/263 • Number of events 16 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	7.6% 20/263 • Number of events 20 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	10.4% 27/260 • Number of events 27 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
General disorders Fatigue	7.9% 21/265 • Number of events 22 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	5.7% 15/263 • Number of events 15 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	3.4% 9/263 • Number of events 9 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	7.7% 20/260 • Number of events 21 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	2.3% 3/133 • Number of events 3 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
General disorders Influenza like illness	5.3% 14/265 • Number of events 14 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	4.6% 12/263 • Number of events 13 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	6.8% 18/263 • Number of events 19 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	3.5% 9/260 • Number of events 9 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	0.75% 1/133 • Number of events 1 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
General disorders Injection site erythema	14.7% 39/265 • Number of events 43 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	11.4% 30/263 • Number of events 30 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	14.8% 39/263 • Number of events 42 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	7.3% 19/260 • Number of events 23 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	1.5% 2/133 • Number of events 2 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
General disorders Injection site pain	67.5% 179/265 • Number of events 198 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	73.0% 192/263 • Number of events 215 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	70.3% 185/263 • Number of events 212 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	67.7% 176/260 • Number of events 192 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	13.5% 18/133 • Number of events 19 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
General disorders Injection site swelling	17.7% 47/265 • Number of events 51 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	13.7% 36/263 • Number of events 40 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	18.6% 49/263 • Number of events 52 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	16.2% 42/260 • Number of events 42 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	3.0% 4/133 • Number of events 4 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.
General disorders Pain	12.8% 34/265 • Number of events 34 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	8.7% 23/263 • Number of events 23 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	11.0% 29/263 • Number of events 30 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	12.3% 32/260 • Number of events 33 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.	1.5% 2/133 • Number of events 2 • Up to Month 24 The at-risk population was randomized participants who received vaccination and had follow-up safety data available.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER