Trial Outcomes & Findings for Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003) (NCT NCT03840174)

Last Updated: 2023-05-06

Results Overview

Participants used the vaccination report card (VRC) to document the presence of any solicited injection-site AEs (pain/tenderness, erythema/redness, and swelling) that occurred in the 5 days after each vaccination. The percentage of participants with a solicited injection-site AE was reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Up to 5 days after each vaccination

Results posted on

2023-05-06

Participant Flow

Healthy male participants 20 to 64 years of age were recruited at study sites in Japan.

Participant milestones

Participant milestones
Measure	V160: CMV Seronegative at Baseline Participants who were cytomegalovirus (CMV)-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	V160: CMV Seropositive at Baseline Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seronegative at Baseline Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo: CMV Seropositive at Baseline Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
Overall Study STARTED	6	6	3	3
Overall Study Vaccination 1	6	6	3	3
Overall Study Vaccination 2	5	6	3	3
Overall Study Vaccination 3	5	6	3	3
Overall Study COMPLETED	5	6	3	3
Overall Study NOT COMPLETED	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	V160: CMV Seronegative at Baseline Participants who were cytomegalovirus (CMV)-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	V160: CMV Seropositive at Baseline Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seronegative at Baseline Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo: CMV Seropositive at Baseline Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
Overall Study Withdrawal by Subject	1	0	0	0

Baseline Characteristics

Safety and Immunogenicity of the Human Cytomegalovirus (CMV) Vaccine (V160) in Healthy Japanese Men (V160-003)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V160: CMV Seropositive at Baseline n=6 Participants Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seropositive at Baseline n=3 Participants Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	V160: CMV Seronegative at Baseline n=6 Participants Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seronegative at Baseline n=3 Participants Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	Total n=18 Participants Total of all reporting groups
Age, Continuous	44.8 Years STANDARD_DEVIATION 16.4 • n=5 Participants	36.3 Years STANDARD_DEVIATION 16.0 • n=7 Participants	33.8 Years STANDARD_DEVIATION 11.5 • n=5 Participants	24.7 Years STANDARD_DEVIATION 5.5 • n=4 Participants	36.4 Years STANDARD_DEVIATION 14.3 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	18 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	6 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	18 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	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) White	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) More than one race	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) 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 5 days after each vaccination

Population: All randomized participants who received at least 1 vaccination

Outcome measures

Outcome measures
Measure	V160: CMV Seronegative at Baseline n=6 Participants Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	V160: CMV Seropositive at Baseline n=6 Participants Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seronegative at Baseline n=3 Participants Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo: CMV Seropositive at Baseline n=3 Participants Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	100.0 Percentage of participants	83.3 Percentage of participants	0.0 Percentage of participants	33.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to 14 days after each vaccination

Population: All randomized participants who received at least 1 vaccination

Participants used the vaccination report card (VRC) to document the presence of any solicited systemic AEs (headache, fatigue, muscle pain, joint pain) that occurred in the 14 days after each vaccination. The percentage of participants with a solicited systemic AE is reported.

Outcome measures

Outcome measures
Measure	V160: CMV Seronegative at Baseline n=6 Participants Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	V160: CMV Seropositive at Baseline n=6 Participants Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seronegative at Baseline n=3 Participants Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo: CMV Seropositive at Baseline n=3 Participants Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
Percentage of Participants With a Solicited Systemic Adverse Event (AE)	33.3 Percentage of participants	16.7 Percentage of participants	33.3 Percentage of participants	66.7 Percentage of participants

PRIMARY outcome

Timeframe: Up to 14 days after each vaccination

Population: All randomized participants who received at least 1 vaccination

An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with an SAE considered to be at least possibly related to the study intervention will be reported

Outcome measures

Outcome measures
Measure	V160: CMV Seronegative at Baseline n=6 Participants Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	V160: CMV Seropositive at Baseline n=6 Participants Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seronegative at Baseline n=3 Participants Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo: CMV Seropositive at Baseline n=3 Participants Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: 1 month after third vaccination (at 7 months)

Population: All randomized participants who were CMV-seronegative at baseline, received all 3 vaccinations, and did not deviate from the protocol in ways that could affect the immune response

The NAb GMT in initially CMV-seronegative participants vaccinated with a 3-dose regimen of V160 administered IM was assessed.

Outcome measures

Outcome measures
Measure	V160: CMV Seronegative at Baseline n=4 Participants Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	V160: CMV Seropositive at Baseline n=3 Participants Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seronegative at Baseline Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo: CMV Seropositive at Baseline Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
Geometric Mean Titer (GMT) of CMV-specific Neutralizing Antibody (NAb)	3651 Geometric Mean Titer Interval 1688.0 to 7895.0	NA Geometric Mean Titer Interval to 115.0 Values below the lower limit of titer (\<94) are represented by NA.	—	—

SECONDARY outcome

Timeframe: Day 1 (predose, at dosing, and 3 hours postdose), Day 3, Day 7, and Day 14

Population: All randomized participants who received at least one vaccination

The number of participants with positive viral detection in plasma (defined by viral load in plasma ≥assay defined threshold cutoff value) was assessed.

Outcome measures

Outcome measures
Measure	V160: CMV Seronegative at Baseline n=6 Participants Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	V160: CMV Seropositive at Baseline n=6 Participants Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seronegative at Baseline n=3 Participants Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo: CMV Seropositive at Baseline n=3 Participants Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
Number of Participants With Viral Detection of V160 in Plasma Day 1 (predose)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Plasma 0 min postdose in Day 1	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Plasma 3 hr postdose in Day 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Plasma Day 3 postdose	6 Participants	6 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Plasma Day 7 postdose	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Plasma Day 14 postdose	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 (predose), 3, 7, and 14 and Months 2, 6, and 7

Population: All randomized participants who received at least one vaccination

The number of participants with positive wild-type viral shedding in urine or saliva (defined by viral load in saliva/urine ≥ assay defined threshold cutoff value) will be assessed.

Outcome measures

Outcome measures
Measure	V160: CMV Seronegative at Baseline n=6 Participants Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	V160: CMV Seropositive at Baseline n=6 Participants Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seronegative at Baseline n=3 Participants Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo: CMV Seropositive at Baseline n=3 Participants Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
Number of Participants With Wild-Type CMV Detection in Urine and Saliva Day 1 (predose)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Wild-Type CMV Detection in Urine and Saliva Day 3 (postdose [PD] 1)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Wild-Type CMV Detection in Urine and Saliva Day 7 (PD1)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Wild-Type CMV Detection in Urine and Saliva Day 14 (PD1)	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Wild-Type CMV Detection in Urine and Saliva Month 2 (predose 2)	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Wild-Type CMV Detection in Urine and Saliva Month 6 (predose 3)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Wild-Type CMV Detection in Urine and Saliva Month 7 (PD3)	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1: 0, 10, 20, and 30 minutes postvaccination

Population: All randomized participants who received at least one vaccination

The number of participants with positive viral leakage in injection-site swab and adhesive tape swab (defined by viral load in injection-site swab/adhesive tape swab ≥ assay defined threshold cutoff value) will be assessed.

Outcome measures

Outcome measures
Measure	V160: CMV Seronegative at Baseline n=6 Participants Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	V160: CMV Seropositive at Baseline n=6 Participants Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seronegative at Baseline n=3 Participants Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo: CMV Seropositive at Baseline n=3 Participants Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab Swab from injection-site - 0 min PD1	6 Participants	6 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab Swab from injection-site - 10 min PD1	3 Participants	4 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab Swab from injection-site - 20 min PD1	4 Participants	4 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab Swab from injection-site - 30 min PD1	3 Participants	4 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab Swab from adhesive tape (inside) - 10 min PD1	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab Swab from adhesive tape (inside) - 20 min PD1	0 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab Swab from adhesive tape (inside) - 30 min PD1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab Swab from adhesive tape (outside) - 10 min PD1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab Swab from adhesive tape (outside) - 20 min PD1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Viral Detection of V160 in Injection-site Swab and Adhesive Tape Swab Swab from adhesive tape (outside) - 30 min PD1	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

V160: CMV Seronegative at Baseline

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

V160: CMV Seropositive at Baseline

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo: CMV Seronegative at Baseline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo: CMV Seropositive at Baseline

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	V160: CMV Seronegative at Baseline n=6 participants at risk Participants who were CMV-seronegative at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	V160: CMV Seropositive at Baseline n=6 participants at risk Participants who were CMV-seropositive at baseline received V160 vaccination by IM injection on Day 1, Month 2, and Month 6. V160 was administered as a 100-unit dose, with aluminum phosphate adjuvant.	Placebo: CMV Seronegative at Baseline n=3 participants at risk Participants who were CMV-seronegative at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo: CMV Seropositive at Baseline n=3 participants at risk Participants who were CMV-seropositive at baseline received placebo by IM injection on Day 1, Month 2, and Month 6.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	16.7% 1/6 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.
General disorders Fatigue	33.3% 2/6 • Number of events 3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	16.7% 1/6 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	33.3% 1/3 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	33.3% 1/3 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.
General disorders Injection site erythema	50.0% 3/6 • Number of events 5 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/6 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	33.3% 1/3 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.
General disorders Injection site pain	66.7% 4/6 • Number of events 10 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	83.3% 5/6 • Number of events 8 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	33.3% 1/3 • Number of events 2 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.
General disorders Injection site swelling	33.3% 2/6 • Number of events 3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	16.7% 1/6 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	33.3% 1/3 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.
Immune system disorders Seasonal allergy	0.00% 0/6 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/6 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	33.3% 1/3 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/6 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	33.3% 1/3 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/6 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	33.3% 1/3 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.
Nervous system disorders Headache	16.7% 1/6 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	16.7% 1/6 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 • Number of events 1 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/6 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.	0.00% 0/3 • Up to 14 days post each vaccination for AE/SAE, and up to 6.5 months for all-cause mortality. All randomized participants who received at least one vaccination are included in safety analysis.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER