Trial Outcomes & Findings for Placebo Controlled, Dose Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004) (NCT NCT02314923)

NCT ID: NCT02314923

Last Updated: 2020-02-05

Results Overview

An AE can 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, tenderness and swelling. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least 1 solicited injection-site AE was summarized by grade.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 513 participants
• Primary outcome timeframe: Up to 14 days postvaccination
• Results posted on: 2020-02-05

Participant Flow

Participant milestones

Measure	3x10^3 Plaque-forming Units (Pfu) V920: Cohort 1 Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 Participants received a single 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 Participants received a single 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 Participants received a single 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 Participants received a single 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Overall Study STARTED	64	64	64	64	74	20	48	47	48	20
Overall Study Treated	64	64	64	64	74	20	47	47	48	20
Overall Study COMPLETED	61	60	62	63	73	19	43	42	46	20
Overall Study NOT COMPLETED	3	4	2	1	1	1	5	5	2	0

Reasons for withdrawal

Measure	3x10^3 Plaque-forming Units (Pfu) V920: Cohort 1 Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 Participants received a single 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 Participants received a single 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 Participants received a single 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 Participants received a single 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Overall Study Death	0	0	0	1	0	0	0	0	0	0
Overall Study Lost to Follow-up	2	3	1	0	0	0	3	4	2	0
Overall Study Withdrawal by Subject	0	0	1	0	1	0	1	0	0	0
Overall Study Physician Decision	0	1	0	0	0	0	0	0	0	0
Overall Study Participant unavailable	0	0	0	0	0	1	0	0	0	0
Overall Study Screen failure	0	0	0	0	0	0	1	0	0	0
Overall Study Participant relocation	1	0	0	0	0	0	0	1	0	0

Baseline Characteristics

Placebo Controlled, Dose Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004)

Baseline characteristics by cohort

Measure	3x10^3 Pfu V920: Cohort 1 n=64 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0	3x10^4 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo Cohort 1 n=74 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 n=47 Participants Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 n=47 Participants Participants received a 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 n=48 Participants Participants received a 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0	Total n=512 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=5 Participants	64 Participants n=7 Participants	64 Participants n=5 Participants	64 Participants n=4 Participants	74 Participants n=21 Participants	20 Participants n=10 Participants	47 Participants n=115 Participants	47 Participants n=24 Participants	48 Participants n=42 Participants	20 Participants n=42 Participants	512 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	33 Participants n=7 Participants	31 Participants n=5 Participants	33 Participants n=4 Participants	39 Participants n=21 Participants	8 Participants n=10 Participants	24 Participants n=115 Participants	22 Participants n=24 Participants	15 Participants n=42 Participants	8 Participants n=42 Participants	245 Participants n=42 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	31 Participants n=7 Participants	33 Participants n=5 Participants	31 Participants n=4 Participants	35 Participants n=21 Participants	12 Participants n=10 Participants	23 Participants n=115 Participants	25 Participants n=24 Participants	33 Participants n=42 Participants	12 Participants n=42 Participants	267 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 14 days postvaccination

Population: All randomized participants who received study vaccination and had data available for the endpoint.

An AE can 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, tenderness and swelling. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least 1 solicited injection-site AE was summarized by grade.

Outcome measures

Measure	3x10^3 Pfu V920: Cohort 1 n=64 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 n=74 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 n=47 Participants Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 n=47 Participants Participants received a 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 n=48 Participants Participants received a 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity Grade 3 (Severe)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity Grade 1 (Mild)	17.2 Percentage of Participants	21.9 Percentage of Participants	29.7 Percentage of Participants	45.3 Percentage of Participants	10.8 Percentage of Participants	30.0 Percentage of Participants	61.7 Percentage of Participants	63.8 Percentage of Participants	47.9 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity Grade 2 (Moderate)	0 Percentage of Participants	1.6 Percentage of Participants	1.6 Percentage of Participants	1.6 Percentage of Participants	1.4 Percentage of Participants	0 Percentage of Participants	8.5 Percentage of Participants	8.5 Percentage of Participants	16.7 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity Grade 4 (Potentially life-threatening)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 14 days postvaccination

Population: All randomized participants who received study vaccination and had data available for the endpoint.

An AE can 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. Systemic AEs included subjective and objective fever, shivering/chills, sweats, myalgia, arthralgia, joint swelling, joint tenderness, fatigue, headache, gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea), mucosal lesion, and skin lesion (including any blisters). AEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one systemic AE was summarized by grade.

Outcome measures

Measure	3x10^3 Pfu V920: Cohort 1 n=64 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 n=74 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 n=47 Participants Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 n=47 Participants Participants received a 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 n=48 Participants Participants received a 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity Grade 1 (Mild)	29.7 Percentage of Participants	39.1 Percentage of Participants	45.3 Percentage of Participants	53.1 Percentage of Participants	41.9 Percentage of Participants	25.0 Percentage of Participants	46.8 Percentage of Participants	46.8 Percentage of Participants	43.8 Percentage of Participants	20.0 Percentage of Participants
Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity Grade 2 (Moderate)	10.9 Percentage of Participants	4.7 Percentage of Participants	10.9 Percentage of Participants	14.1 Percentage of Participants	4.1 Percentage of Participants	25.0 Percentage of Participants	19.1 Percentage of Participants	23.4 Percentage of Participants	27.1 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity Grade 3 (Severe)	0 Percentage of Participants	0 Percentage of Participants	3.1 Percentage of Participants	1.6 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	2.1 Percentage of Participants	4.3 Percentage of Participants	4.2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity Grade 4 (Potentially life-threatening)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 56 days postvaccination

Population: All randomized participants who received study vaccination and had data available for the endpoint.

An AE can 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. Unsolicited vaccine-related AEs were those events not specifically listed as either an injection-site (local) or systemic in the VRC and were reported as at least possibly related to the study vaccine or placebo. The AEs were further assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one unsolicited vaccine-related AE was summarized by grade..

Outcome measures

Measure	3x10^3 Pfu V920: Cohort 1 n=64 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 n=74 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 n=47 Participants Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 n=47 Participants Participants received a 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 n=48 Participants Participants received a 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity 2 (Moderate)	4.7 Percentage of Participants	3.1 Percentage of Participants	0 Percentage of Participants	3.1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	6.4 Percentage of Participants	2.1 Percentage of Participants	2.1 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity 1 (Mild)	7.8 Percentage of Participants	14.1 Percentage of Participants	7.8 Percentage of Participants	9.4 Percentage of Participants	6.8 Percentage of Participants	15.0 Percentage of Participants	14.9 Percentage of Participants	17.0 Percentage of Participants	14.6 Percentage of Participants	10.0 Percentage of Participants
Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity 3 (Severe)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	1.6 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity 4 (Potentially Life-threatening)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 360 days postvaccination

Population: All randomized participants who received study vaccination and had data available for the endpoint.

An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An SAE is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. SAEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening; 5=Fatal. The percentage of participants that experienced at least 1 SAE was summarized by grade.

Outcome measures

Measure	3x10^3 Pfu V920: Cohort 1 n=64 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 n=74 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 n=47 Participants Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 n=47 Participants Participants received a 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 n=48 Participants Participants received a 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity 1 (Mild)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	1.6 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity 2 (Moderate)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity 3 (Severe)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	1.4 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity 4 (Potentially Life-threatening)	0 Percentage of Participants	0 Percentage of Participants	1.6 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity 5 (Fatal)	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	1.6 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

PRIMARY outcome

Timeframe: 28 days postvaccination

Population: All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.

Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	3x10^3 Pfu V920: Cohort 1 n=64 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 n=61 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 n=63 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 n=25 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 n=45 Participants Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 n=46 Participants Participants received a 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 n=45 Participants Participants received a 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Geometric Mean Titers (GMTs) of Zaire Ebola Virus- (ZEBOV)-Specific Immunoglobulin-G (IgG) Antibody	777.8 ELISA Units/mL Standard Deviation 5.06	767.8 ELISA Units/mL Standard Deviation 3.96	909.6 ELISA Units/mL Standard Deviation 3.26	1139.9 ELISA Units/mL Standard Deviation 3.25	30.3 ELISA Units/mL Standard Deviation 1.00	1518.9 ELISA Units/mL Standard Deviation 3.20	977.4 ELISA Units/mL Standard Deviation 3.01	1542.8 ELISA Units/mL Standard Deviation 3.10	1930.3 ELISA Units/mL Standard Deviation 2.22	35.9 ELISA Units/mL Standard Deviation 2.13

PRIMARY outcome

Timeframe: Day 360

Population: All participants who received study vaccine

The optimum dose for general use prophylaxis with V920 was determined following the review of all immunogenicity and safety data.

Outcome measures

Measure	3x10^3 Pfu V920: Cohort 1 n=512 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 Participants received a 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 Participants received a 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 Participants received a 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 Participants received a 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Optimum Dose for General Use Prophylaxis With V920	20000000 pfu	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1, 2, 3, 4, 7, 14 and 28 post-vaccination

Population: All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.

Participants had blood, assessed for evidence of V920 via polymerase chain reaction (PCR). Mean copies of RNA was reported for all participants who had reading ≥ the LLOQ (62.5 copies/mL)

Outcome measures

Measure	3x10^3 Pfu V920: Cohort 1 n=64 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 n=61 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 n=63 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 n=25 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 n=45 Participants Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 n=46 Participants Participants received a 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 n=45 Participants Participants received a 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ) Day 1	—	—	—	118.04 copies/mL Standard Deviation 1.185	—	109.40 copies/mL Standard Deviation NA SD could not be calculated due to low n	144.72 copies/mL Standard Deviation 1.511	184.65 copies/mL Standard Deviation 1.893	304.45 copies/mL Standard Deviation 2.534	—
Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ) Day 2	4107.00 copies/mL Standard Deviation NA SD could not be calculated due to low n	—	—	127.13 copies/mL Standard Deviation 1.511	—	109.40 copies/mL Standard Deviation NA SD could not be calculated due to low n	158.74 copies/mL Standard Deviation 1.901	172.24 copies/mL Standard Deviation 1.628	161.67 copies/mL Standard Deviation 1.644	—
Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ) Day 3	12649.00 copies/mL Standard Deviation NA SD could not be calculated due to low n	109.40 copies/mL Standard Deviation NA SD could not be calculated due to low n	—	703.36 copies/mL Standard Deviation 25.106	—	—	—	109.40 copies/mL Standard Deviation NA SD could not be calculated due to low n	740.96 copies/mL Standard Deviation 8.199	—
Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ) Day 4	23936.00 copies/mL Standard Deviation NA SD could not be calculated due to low n	109.40 copies/mL Standard Deviation NA SD could not be calculated due to low n	—	—	—	—	—	—	—	—
Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ) Day 7	787.00 copies/mL Standard Deviation NA SD could not be calculated due to low n	—	160.00 copies/mL Standard Deviation NA SD could not be calculated due to low n	—	—	—	—	—	—	—
Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ) Day 14	—	—	—	109.40 copies/mL Standard Deviation NA SD could not be calculated due to low n	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination

Population: All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.

Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 ELISA Units/mL that was also at least a 4-fold increase in titer compared to baseline.

Outcome measures

Measure	3x10^3 Pfu V920: Cohort 1 n=64 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 n=61 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 n=63 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 n=25 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 n=45 Participants Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 n=46 Participants Participants received a 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 n=45 Participants Participants received a 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Percentage of Participants With Seroconversion for ZEBOV-specific IgG Day 7	0 Percentage of Participants	1.7 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	2.2 Percentage of Participants	2.2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Seroconversion for ZEBOV-specific IgG Day 14	11.5 Percentage of Participants	20.3 Percentage of Participants	20.6 Percentage of Participants	50.0 Percentage of Participants	0 Percentage of Participants	40.0 Percentage of Participants	54.5 Percentage of Participants	81.8 Percentage of Participants	72.7 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Seroconversion for ZEBOV-specific IgG Day 28	82.8 Percentage of Participants	80.3 Percentage of Participants	89.1 Percentage of Participants	93.7 Percentage of Participants	0 Percentage of Participants	90.0 Percentage of Participants	91.1 Percentage of Participants	93.5 Percentage of Participants	95.6 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With Seroconversion for ZEBOV-specific IgG Day 56	85.7 Percentage of Participants	86.9 Percentage of Participants	92.2 Percentage of Participants	93.7 Percentage of Participants	0 Percentage of Participants	90.0 Percentage of Participants	93.2 Percentage of Participants	97.8 Percentage of Participants	97.8 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Seroconversion for ZEBOV-specific IgG Day 84	81.7 Percentage of Participants	85.2 Percentage of Participants	87.3 Percentage of Participants	93.4 Percentage of Participants	0 Percentage of Participants	—	—	—	—	—
Percentage of Participants With Seroconversion for ZEBOV-specific IgG Day 180	82.0 Percentage of Participants	75.9 Percentage of Participants	83.6 Percentage of Participants	89.9 Percentage of Participants	—	94.4 Percentage of Participants	90.2 Percentage of Participants	97.6 Percentage of Participants	97.6 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Seroconversion for ZEBOV-specific IgG Day 360	78.4 Percentage of Participants	75.0 Percentage of Participants	80.4 Percentage of Participants	89.5 Percentage of Participants	0 Percentage of Participants	94.4 Percentage of Participants	89.5 Percentage of Participants	97.4 Percentage of Participants	93.2 Percentage of Participants	—
Percentage of Participants With Seroconversion for ZEBOV-specific IgG Any time postvaccination	89.1 Percentage of Participants	90.2 Percentage of Participants	93.8 Percentage of Participants	96.8 Percentage of Participants	0 Percentage of Participants	100.0 Percentage of Participants	97.8 Percentage of Participants	97.8 Percentage of Participants	97.8 Percentage of Participants	5.0 Percentage of Participants

SECONDARY outcome

Timeframe: 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination

Population: All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.

Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined plaque reduction neutralization titer (reciprocal of the dilution that resulted in a 60% decrease in plaques) (PRNT60).

Outcome measures

Measure	3x10^3 Pfu V920: Cohort 1 n=64 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 n=61 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 n=64 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 n=63 Participants Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 n=25 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 n=45 Participants Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 n=46 Participants Participants received a 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 n=45 Participants Participants received a 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 n=20 Participants Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies Day 7	0 Percentage of Participants	0 Percentage of Participants	1.6 Percentage of Participants	1.6 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	2.2 Percentage of Participants	2.2 Percentage of Participants	2.2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies Day 14	9.5 Percentage of Participants	13.6 Percentage of Participants	42.9 Percentage of Participants	52.4 Percentage of Participants	0 Percentage of Participants	45.0 Percentage of Participants	55.6 Percentage of Participants	71.1 Percentage of Participants	81.8 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies Day 28	76.2 Percentage of Participants	70.5 Percentage of Participants	87.5 Percentage of Participants	93.7 Percentage of Participants	0 Percentage of Participants	85.0 Percentage of Participants	91.1 Percentage of Participants	95.7 Percentage of Participants	100.0 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies Day 56	79.4 Percentage of Participants	70.5 Percentage of Participants	89.1 Percentage of Participants	93.7 Percentage of Participants	0 Percentage of Participants	90.0 Percentage of Participants	93.2 Percentage of Participants	95.7 Percentage of Participants	97.8 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies Day 84 (Cohort 1 only)	75.8 Percentage of Participants	72.1 Percentage of Participants	88.9 Percentage of Participants	90.3 Percentage of Participants	4.0 Percentage of Participants	—	—	—	—	—
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies Day 180	81.0 Percentage of Participants	81.0 Percentage of Participants	88.5 Percentage of Participants	91.9 Percentage of Participants	0 Percentage of Participants	94.4 Percentage of Participants	95.2 Percentage of Participants	95.2 Percentage of Participants	100.0 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies Day 360	77.4 Percentage of Participants	78.8 Percentage of Participants	82.1 Percentage of Participants	93.0 Percentage of Participants	0 Percentage of Participants	94.4 Percentage of Participants	84.6 Percentage of Participants	97.5 Percentage of Participants	100.0 Percentage of Participants	5.3 Percentage of Participants
Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies Any time postvaccination	89.1 Percentage of Participants	88.5 Percentage of Participants	96.9 Percentage of Participants	98.4 Percentage of Participants	4.0 Percentage of Participants	100.0 Percentage of Participants	97.8 Percentage of Participants	100.0 Percentage of Participants	100.0 Percentage of Participants	10.0 Percentage of Participants

Adverse Events

3x10^3 Pfu V920: Cohort 1

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

3x10^4 Pfu V920: Cohort 1

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

3x10^5 Pfu V920: Cohort 1

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

3x10^6 Pfu V920: Cohort 1

Serious events: 2 serious events

Other events: 52 other events

Deaths: 1 deaths

Placebo: Cohort 1

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

3x10^6 Pfu V920: Cohort 2

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

9x10^6 Pfu V920: Cohort 2

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

2x10^7 Pfu V920: Cohort 2

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

1x10^8 Pfu V920: Cohort 2

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Placebo: Cohort 2

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	3x10^3 Pfu V920: Cohort 1 n=64 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 n=64 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 n=64 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 n=64 participants at risk Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 n=74 participants at risk Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 n=20 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 n=47 participants at risk Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 n=47 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 n=48 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 n=20 participants at risk Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
General disorders Chest pain	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/74 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/48 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Injury, poisoning and procedural complications Head injury	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/74 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/48 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.4% 1/74 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/48 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Nervous system disorders Presyncope	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/74 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/48 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Vascular disorders Peripheral ischaemia	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.4% 1/74 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/48 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).

Other adverse events

Measure	3x10^3 Pfu V920: Cohort 1 n=64 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 3x10\^3 pfu in the deltoid on Day 0.	3x10^4 Pfu V920: Cohort 1 n=64 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 3x10\^4 pfu in the deltoid on Day 0.	3x10^5 Pfu V920: Cohort 1 n=64 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 3x10\^5 pfu in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 1 n=64 participants at risk Participants received a 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0.	Placebo: Cohort 1 n=74 participants at risk Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.	3x10^6 Pfu V920: Cohort 2 n=20 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 3x10\^6 pfu in the deltoid on Day 0	9x10^6 Pfu V920: Cohort 2 n=47 participants at risk Participants received a 1.0 mL intramuscular injection of V920 9x10\^6 pfu in the deltoid on Day 0.	2x10^7 Pfu V920: Cohort 2 n=47 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 2x10\^7 pfu in the deltoid on Day 0.	1x10^8 Pfu V920: Cohort 2 n=48 participants at risk Participants received a single 1.0 mL intramuscular injection of V920 1x10\^8 pfu in the deltoid on Day 0.	Placebo: Cohort 2 n=20 participants at risk Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Gastrointestinal disorders Abdominal pain	10.9% 7/64 • Number of events 9 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.7% 3/64 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	9.4% 6/64 • Number of events 7 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	3.1% 2/64 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.4% 4/74 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	8.5% 4/47 • Number of events 4 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	6.4% 3/47 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	10.4% 5/48 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.0% 1/20 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Gastrointestinal disorders Diarrhoea	9.4% 6/64 • Number of events 13 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	3.1% 2/64 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	9.4% 6/64 • Number of events 7 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	9.4% 6/64 • Number of events 7 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	10.8% 8/74 • Number of events 9 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	10.0% 2/20 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	14.9% 7/47 • Number of events 8 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	12.8% 6/47 • Number of events 7 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	22.9% 11/48 • Number of events 13 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.0% 1/20 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Gastrointestinal disorders Nausea	14.1% 9/64 • Number of events 9 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	9.4% 6/64 • Number of events 7 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	20.3% 13/64 • Number of events 14 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	17.2% 11/64 • Number of events 13 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	16.2% 12/74 • Number of events 14 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	20.0% 4/20 • Number of events 4 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	8.5% 4/47 • Number of events 4 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	10.6% 5/47 • Number of events 7 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	12.5% 6/48 • Number of events 6 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	15.0% 3/20 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Gastrointestinal disorders Vomiting	4.7% 3/64 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	3.1% 2/64 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	6.2% 4/64 • Number of events 4 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	7.8% 5/64 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.4% 4/74 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.0% 1/20 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	2.1% 1/47 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	2.1% 1/47 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	6.2% 3/48 • Number of events 4 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
General disorders Chills	9.4% 6/64 • Number of events 6 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.7% 3/64 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	10.9% 7/64 • Number of events 8 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	32.8% 21/64 • Number of events 22 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	8.1% 6/74 • Number of events 6 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	15.0% 3/20 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	34.0% 16/47 • Number of events 18 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	27.7% 13/47 • Number of events 14 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	31.2% 15/48 • Number of events 17 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.0% 1/20 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
General disorders Fatigue	18.8% 12/64 • Number of events 13 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	20.3% 13/64 • Number of events 16 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	21.9% 14/64 • Number of events 17 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	32.8% 21/64 • Number of events 24 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	18.9% 14/74 • Number of events 16 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	30.0% 6/20 • Number of events 6 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	36.2% 17/47 • Number of events 22 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	38.3% 18/47 • Number of events 25 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	45.8% 22/48 • Number of events 25 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	20.0% 4/20 • Number of events 6 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
General disorders Pyrexia	4.7% 3/64 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	6.2% 4/64 • Number of events 6 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	9.4% 6/64 • Number of events 6 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	25.0% 16/64 • Number of events 19 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.1% 3/74 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	30.0% 6/20 • Number of events 8 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	29.8% 14/47 • Number of events 18 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	38.3% 18/47 • Number of events 24 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	31.2% 15/48 • Number of events 20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
General disorders Swelling	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/74 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.3% 2/47 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	6.4% 3/47 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	2.1% 1/48 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
General disorders Tenderness	15.6% 10/64 • Number of events 10 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	18.8% 12/64 • Number of events 14 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	25.0% 16/64 • Number of events 17 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	40.6% 26/64 • Number of events 27 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	9.5% 7/74 • Number of events 7 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	20.0% 4/20 • Number of events 4 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	59.6% 28/47 • Number of events 29 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	59.6% 28/47 • Number of events 28 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	50.0% 24/48 • Number of events 24 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.0% 1/20 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Infections and infestations Bronchitis	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	2.7% 2/74 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	10.0% 2/20 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/48 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Infections and infestations Upper respiratory tract infection	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	3.1% 2/64 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	8.1% 6/74 • Number of events 6 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	2.1% 1/47 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/48 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Investigations Alanine aminotransferase increased	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	3.1% 2/64 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/74 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.3% 2/47 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.3% 2/47 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.2% 2/48 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	15.0% 3/20 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Investigations Haemoglobin decreased	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/74 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.3% 2/47 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.3% 2/47 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	2.1% 1/48 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	10.0% 2/20 • Number of events 4 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Musculoskeletal and connective tissue disorders Arthralgia	14.1% 9/64 • Number of events 18 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	17.2% 11/64 • Number of events 23 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	23.4% 15/64 • Number of events 23 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	17.2% 11/64 • Number of events 24 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	12.2% 9/74 • Number of events 13 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	20.0% 4/20 • Number of events 6 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	21.3% 10/47 • Number of events 22 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	23.4% 11/47 • Number of events 30 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	14.6% 7/48 • Number of events 21 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	10.0% 2/20 • Number of events 10 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Musculoskeletal and connective tissue disorders Joint swelling	4.7% 3/64 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	3.1% 2/64 • Number of events 4 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	3.1% 2/64 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.7% 3/64 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/74 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.0% 1/20 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	6.4% 3/47 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	8.5% 4/47 • Number of events 7 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/48 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.0% 1/20 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Musculoskeletal and connective tissue disorders Myalgia	18.8% 12/64 • Number of events 15 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	20.3% 13/64 • Number of events 16 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	23.4% 15/64 • Number of events 16 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	21.9% 14/64 • Number of events 15 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	13.5% 10/74 • Number of events 11 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	40.0% 8/20 • Number of events 12 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	40.4% 19/47 • Number of events 22 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	34.0% 16/47 • Number of events 18 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	33.3% 16/48 • Number of events 18 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.0% 1/20 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Musculoskeletal and connective tissue disorders Pain in extremity	7.8% 5/64 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	10.9% 7/64 • Number of events 7 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	18.8% 12/64 • Number of events 12 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	31.2% 20/64 • Number of events 20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	8.1% 6/74 • Number of events 6 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	20.0% 4/20 • Number of events 4 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	59.6% 28/47 • Number of events 30 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	57.4% 27/47 • Number of events 28 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	52.1% 25/48 • Number of events 25 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.0% 1/20 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Nervous system disorders Dizziness	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	6.2% 4/64 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/74 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.0% 1/20 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	2.1% 1/48 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Nervous system disorders Headache	23.4% 15/64 • Number of events 24 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	29.7% 19/64 • Number of events 23 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	31.2% 20/64 • Number of events 27 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	50.0% 32/64 • Number of events 41 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	31.1% 23/74 • Number of events 33 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	35.0% 7/20 • Number of events 12 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	48.9% 23/47 • Number of events 32 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	46.8% 22/47 • Number of events 30 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	43.8% 21/48 • Number of events 28 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	15.0% 3/20 • Number of events 11 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/74 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	2.1% 1/47 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	10.6% 5/47 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	2.1% 1/48 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Skin and subcutaneous tissue disorders Hyperhidrosis	9.4% 6/64 • Number of events 7 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.7% 3/64 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	7.8% 5/64 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	7.8% 5/64 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.1% 3/74 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	20.0% 4/20 • Number of events 4 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	12.8% 6/47 • Number of events 7 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	23.4% 11/47 • Number of events 12 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	27.1% 13/48 • Number of events 15 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/74 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.3% 2/47 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.3% 2/47 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	6.2% 3/48 • Number of events 5 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).
Vascular disorders Hypertension	4.7% 3/64 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	1.6% 1/64 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	3.1% 2/64 • Number of events 2 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/64 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	4.1% 3/74 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	5.0% 1/20 • Number of events 1 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	6.4% 3/47 • Number of events 3 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/47 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/48 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).	0.00% 0/20 • Up to 360 days All participants that received study vaccination (V920 dose or placebo).

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 All data may be published in the open medical literature with the identity of the subjects protected. Anyone desiring to publish or present data obtained during the conduct of the study will conform to the Sponsor's policies and then forward the publication for review to the Sponsor prior to submission.
• Publication restrictions are in place

Restriction type: OTHER