Trial Outcomes & Findings for Vaccine Treatment for Ebola Virus in Healthy Adults (V920-001) (NCT NCT02269423)

NCT ID: NCT02269423

Last Updated: 2019-10-23

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event (TEAE) is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). The number of participants that experienced at least one solicited local TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 39 participants
• Primary outcome timeframe: Up to 14 days postvaccination
• Results posted on: 2019-10-23

Participant Flow

Participant milestones

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Overall Study STARTED	10	10	10	9
Overall Study COMPLETED	10	9	10	8
Overall Study NOT COMPLETED	0	1	0	1

Reasons for withdrawal

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Overall Study Discontinued due to change in residence	0	1	0	1

Baseline Characteristics

Vaccine Treatment for Ebola Virus in Healthy Adults (V920-001)

Baseline characteristics by cohort

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.	Total n=39 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
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	39 Participants n=21 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
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	5 Participants n=4 Participants	27 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	36 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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
Race (NIH/OMB) American Indian or Alaska Native	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
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	16 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	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

PRIMARY outcome

Timeframe: Up to 14 days postvaccination

Population: All randomized participants who received study vaccination (V920 dose level or placebo).

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event (TEAE) is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). The number of participants that experienced at least one solicited local TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE)	8 Participants	8 Participants	10 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to 14 days postvaccination

Population: All randomized participants who received study vaccination (V920 dose level or placebo).

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's 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 number of participants that experienced at least one solicited local TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) by Severity Grade 1 (Mild)	6 Participants	7 Participants	9 Participants	3 Participants
Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) by Severity Grade 2 (Moderate)	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) by Severity Grade 3 (Severe)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) by Severity Grade 4 (Potentially life-threatening)	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 14 days postvaccination

Population: All randomized participants who received study vaccination (V920 dose level or placebo).

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. The number of participants that experienced at least one solicited systemic TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE)	9 Participants	7 Participants	9 Participants	6 Participants

PRIMARY outcome

Timeframe: Up to 14 days postvaccination

Population: All randomized participants who received study vaccination (V920 dose level or placebo).

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. 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 number of participants that experienced at least 1 solicited systemic TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE) by Severity Grade 1 (Mild)	3 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE) by Severity Grade 2 (Moderate)	3 Participants	3 Participants	4 Participants	1 Participants
Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE) by Severity Grade 3 (Severe)	3 Participants	2 Participants	3 Participants	0 Participants
Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE) by Severity Grade 4 (Potentially life-threatening)	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 28 days postvaccination

Population: All randomized participants who received study vaccination (V920 dose level or placebo).

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. The number of participants that experienced at least one unsolicited TEAE was assessed. Unsolicited AEs occurred from the time of injection through 28 days following injection.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Number of Participants With One or More Unsolicited Treatment-Emergent Adverse Events (TEAE)	10 Participants	9 Participants	9 Participants	8 Participants

PRIMARY outcome

Timeframe: Up to 28 days postvaccination

Population: All randomized participants who received study vaccination (V920 dose or placebo).

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. The number of participants that experienced at least one unsolicited TEAE related to study vaccination was assessed.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE)	8 Participants	8 Participants	7 Participants	6 Participants

PRIMARY outcome

Timeframe: Up to 28 days postvaccination

Population: All randomized participants who received study vaccination (V920 dose level or placebo).

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's 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 number of participants that experienced at least one unsolicited TEAE related to study vaccination was summarized by grade.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE) by Severity Grade 1 (Mild)	1 Participants	2 Participants	2 Participants	5 Participants
Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE) by Severity Grade 2 (Moderate)	3 Participants	3 Participants	3 Participants	1 Participants
Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE) by Severity Grade 3 (Severe)	4 Participants	3 Participants	2 Participants	0 Participants
Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE) by Severity Grade 4 (Potentially life-threatening)	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 28 days postvaccination

Population: All randomized participants who received study vaccination (V920 dose level or placebo).

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. The number of participants prematurely withdrawing from the study due to an AE was assessed.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Number of Participants With Early Study Discontinuation Due to an Adverse Event	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 180 days postvaccination

Population: All participants who received study vaccination (V920 dose level or placebo).

An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The number of participants that experienced one or more SAE was summarized.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Number of Participants With One or More Serious Adverse Event	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Days 7, 14, 28, 56, 84 and 180 post-vaccination

Population: All randomized participants who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints for the specified measurement and timeframe.

The Geometric Mean Titers (GMT) of ZEBOV-specific Immunoglobulin G antibodies were measured by unqualified ZEBOV immunoglobulin (IgG) enzyme-linked immunosorbent assay (ELISA). For titers expressed in ELISA Units/mL, the lower level of quantitation (LLOQ) was 58.84. ZEBOV IgG titers at baseline (Day 0) and analysis Days 7, 14, 28, 56, 84, and 180 were summarized by V920 vaccine dose level and placebo as the mean of log10 titers, transformed into GMT. The geometric standard deviation (GSD) for the GMT at each visit was obtained by exponentiating the standard deviation for the mean of log (base 10) transformed titers.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies Baseline (Day 0)	29.42 ELISA Units/mL Standard Deviation 1.00	29.42 ELISA Units/mL Standard Deviation 1.00	33.85 ELISA Units/mL Standard Deviation 1.56	35.09 ELISA Units/mL Standard Deviation 1.70
Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies Day 7	29.42 ELISA Units/mL Standard Deviation 1.00	29.42 ELISA Units/mL Standard Deviation 1.00	29.42 ELISA Units/mL Standard Deviation 1.00	34.92 ELISA Units/mL Standard Deviation 1.67
Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies Day 14	225.23 ELISA Units/mL Standard Deviation 2.15	360.14 ELISA Units/mL Standard Deviation 4.04	621.68 ELISA Units/mL Standard Deviation 5.45	35.24 ELISA Units/mL Standard Deviation 1.72
Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies Day 28	911.79 ELISA Units/mL Standard Deviation 2.09	1570.84 ELISA Units/mL Standard Deviation 2.40	2662.23 ELISA Units/mL Standard Deviation 2.88	36.54 ELISA Units/mL Standard Deviation 1.92
Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies Day 56	1425.16 ELISA Units/mL Standard Deviation 2.14	2031.53 ELISA Units/mL Standard Deviation 2.02	2677.04 ELISA Units/mL Standard Deviation 3.59	31.81 ELISA Units/mL Standard Deviation 1.26
Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies Day 84	1245.40 ELISA Units/mL Standard Deviation 1.96	1816.81 ELISA Units/mL Standard Deviation 2.14	2374.33 ELISA Units/mL Standard Deviation 4.36	31.85 ELISA Units/mL Standard Deviation 1.27
Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies Day 180	1494.69 ELISA Units/mL Standard Deviation 3.21	1177.40 ELISA Units/mL Standard Deviation 2.22	1658.50 ELISA Units/mL Standard Deviation 3.13	39.44 ELISA Units/mL Standard Deviation 2.17

SECONDARY outcome

Timeframe: Baseline, Days 7, 14, 28, 56, and 180 post-vaccination

Population: All randomized participants who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints for the specified measurement and timeframe.

The Geometric Mean Titers (GMT) of ZEBOV-specific neutralizing antibodies were measured by pseudovirion neutralization assays (PsVNA). Titers were reported for PsVNA50 values which were derived from the reciprocal of the dilution that resulted in a 50% decrease in luciferase activity. The LLOQ for the PsVNA was 20. If the PsVNA was reported ≤20, the numeric portion of the titer was divided by 2 for statistical purposes, which could result in a reported GMT <20.0. PsVNA50 titers at baseline (Day 0) and analysis Days 7, 14, 28, 56, and 180 were summarized by V920 vaccine dose level and placebo as the mean of log10 titers, transformed into GMT. The geometric standard deviation (GSD) for the GMT at each visit was obtained by exponentiating the standard deviation for the mean of log (base 10) transformed titers.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies Baseline	10.0 titer Standard Deviation 1.00	10.0 titer Standard Deviation 1.00	10.0 titer Standard Deviation 1.00	10.0 titer Standard Deviation 1.00
Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies Day 7	10.0 titer Standard Deviation 1.00	10.0 titer Standard Deviation 1.00	10.0 titer Standard Deviation 1.00	10.0 titer Standard Deviation 1.00
Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies Day 14	46.0 titer Standard Deviation 2.83	216.5 titer Standard Deviation 3.29	140.4 titer Standard Deviation 3.58	10.0 titer Standard Deviation 1.00
Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies Day 28	222.8 titer Standard Deviation 3.20	468.0 titer Standard Deviation 3.96	447.0 titer Standard Deviation 2.10	10.0 titer Standard Deviation 1.00
Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies Day 56	137.7 titer Standard Deviation 2.38	170.3 titer Standard Deviation 1.86	218.6 titer Standard Deviation 3.06	10.0 titer Standard Deviation 1.00
Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies Day 180	29.1 titer Standard Deviation 4.23	23.0 titer Standard Deviation 2.90	46.2 titer Standard Deviation 3.06	10.0 titer Standard Deviation 1.00

SECONDARY outcome

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

Population: All randomized subjects who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints.

The number of participants with viremia detected by recombinant vesicular stomatitis virus (rVSV) reverse transcription polymerase chain reaction (PCR) of blood specimens was assessed.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Number of Participants With Vaccine Viremia Day 1	10 Participants	10 Participants	10 Participants	0 Participants
Number of Participants With Vaccine Viremia Day 3	10 Participants	10 Participants	9 Participants	1 Participants
Number of Participants With Vaccine Viremia Day 7	1 Participants	2 Participants	3 Participants	0.0 Participants
Number of Participants With Vaccine Viremia Day 14	0.0 Participants	0.0 Participants	0.0 Participants	0.0 Participants

SECONDARY outcome

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

Population: All randomized subjects who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints.

The number of participants with viremia detected by rVSV reverse transcription PCR of saliva or urine specimens was assessed.

Outcome measures

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 Participants Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 Participants Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Number of Participants With Vaccine Shedding/Excretion in Saliva or Urine Day 1	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Vaccine Shedding/Excretion in Saliva or Urine Day 3	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Vaccine Shedding/Excretion in Saliva or Urine Day 7	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Vaccine Shedding/Excretion in Saliva or Urine Day 14	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 14 days postvaccination

Population: Although the plan specified in the protocol was to describe vector viremia by summarizing simple mean copy numbers of vector RNA, this data was not collected as the PCR results were qualitative rather than quantitative and were assessed in outcome measures # 12 and #13 instead.

Although the protocol specified a secondary endpoint that included the mean copy number of vector RNA (vector viremia), the Polymerase Chain Reaction (PCR) test used for the study reported a qualitative rather than a quantitative outcome, so the proportion of participants with viremia is reported instead of the mean copy number of vector RNA. Qualitative results are therefore reported in Outcome Measures 12 and 13.

Outcome measures

Outcome data not reported

Adverse Events

3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

2x10^7 Pfu Vaccine Cohort

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

1x10^8 Pfu Vaccine Cohort

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo Cohort

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort n=10 participants at risk Participants will receive a 1-mL intramuscular injection of V920 3x10\^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	2x10^7 Pfu Vaccine Cohort n=10 participants at risk Participants will receive a 1-mL intramuscular injection of V920 2x10\^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	1x10^8 Pfu Vaccine Cohort n=10 participants at risk Participants will receive a 1-mL intramuscular injection of V920 1x10\^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.	Placebo Cohort n=9 participants at risk Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
Blood and lymphatic system disorders Anemia	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Blood and lymphatic system disorders Lymphopenia	70.0% 7/10 • Number of events 7 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	20.0% 2/10 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Blood and lymphatic system disorders Neutropenia	30.0% 3/10 • Number of events 3 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Eye disorders Blepharospasm	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Eye disorders Photophobia	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Gastrointestinal disorders Abdominal pain	20.0% 2/10 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	20.0% 2/10 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	20.0% 2/10 • Number of events 3 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Gastrointestinal disorders Diarrhea	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	20.0% 2/10 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Gastrointestinal disorders Nausea	20.0% 2/10 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	30.0% 3/10 • Number of events 4 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	20.0% 2/10 • Number of events 3 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Gastrointestinal disorders Vomiting	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
General disorders Chills	30.0% 3/10 • Number of events 3 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	40.0% 4/10 • Number of events 4 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	70.0% 7/10 • Number of events 7 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
General disorders Fatigue	60.0% 6/10 • Number of events 9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	40.0% 4/10 • Number of events 5 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	70.0% 7/10 • Number of events 12 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	44.4% 4/9 • Number of events 4 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
General disorders Injection site bruising	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
General disorders Injection site pain	80.0% 8/10 • Number of events 8 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	80.0% 8/10 • Number of events 11 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	100.0% 10/10 • Number of events 15 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	44.4% 4/9 • Number of events 5 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
General disorders Injection site swelling	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
General disorders Pyrexia	40.0% 4/10 • Number of events 7 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	40.0% 4/10 • Number of events 6 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	80.0% 8/10 • Number of events 13 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Infections and infestations Pharyngitis	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Infections and infestations Pharyngitis streptococcal	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Infections and infestations Sinusitis	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Infections and infestations Upper respiratory tract infection	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	20.0% 2/10 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Investigations Alanine aminotransferase increased	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	22.2% 2/9 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Investigations Aspartate aminotransferase increased	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	22.2% 2/9 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Investigations Blood urea increased	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Investigations Hemoglobin decreased	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	30.0% 3/10 • Number of events 3 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	22.2% 2/9 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Investigations Lymphocyte count decreased	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	70.0% 7/10 • Number of events 7 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	50.0% 5/10 • Number of events 5 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Investigations Platelet count decreased	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	20.0% 2/10 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Investigations Prothrombin time prolonged	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	33.3% 3/9 • Number of events 3 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Investigations White blood cell count decreased	20.0% 2/10 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	20.0% 2/10 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	30.0% 3/10 • Number of events 3 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Investigations White blood cell count increased	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Investigations Neutrophil count decreased	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	20.0% 2/10 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	30.0% 3/10 • Number of events 3 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	50.0% 5/10 • Number of events 6 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	22.2% 2/9 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Musculoskeletal and connective tissue disorders Myalgia	60.0% 6/10 • Number of events 6 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	40.0% 4/10 • Number of events 4 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	60.0% 6/10 • Number of events 6 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Nervous system disorders Dizziness postural	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Nervous system disorders Headache	60.0% 6/10 • Number of events 11 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	60.0% 6/10 • Number of events 8 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	80.0% 8/10 • Number of events 14 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	77.8% 7/9 • Number of events 10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Nervous system disorders Sinus headache	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Psychiatric disorders Phobia	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Renal and urinary disorders Hematuria	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Renal and urinary disorders Proteinuria	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	20.0% 2/10 • Number of events 2 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/9 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/10 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	10.0% 1/10 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	40.0% 4/10 • Number of events 4 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.	11.1% 1/9 • Number of events 1 • Up to 180 days All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data. The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.

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 or military 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 WRAIR, USAMRIID, and the sponsor's policies and then forward the publication for review to the sponsor and usarmy.detrick.medcom-usamrmc.list.clearances@mail.mil prior to submission.
• Publication restrictions are in place

Restriction type: OTHER