Trial Outcomes & Findings for Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003) (NCT NCT05507450)

Last Updated: 2025-05-09

Results Overview

A dengue VRNT was conducted to assess neutralizing antibody Geometric Mean Titers (GMTs) for each of the 4 dengue vaccine serotypes (DENV1, DENV2, DENV3, and DENV4) in specimens collected from participants on Day 28 post-vaccination.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1271 participants

Primary outcome timeframe

Day 28 post-vaccination

Results posted on

2025-05-09

Participant Flow

Adult males or females, in generally good health, between 18 to 50 years of age, and without a history of dengue or Zika natural infection or prior receipt of any other dengue vaccine were enrolled in this study.

Participant milestones

Participant milestones
Measure	V181 High-Potency Level Group Participants received a single 0.5 mL subcutaneous (SC) dose of V181 High-Potency vaccine.	V181 Mid-Potency Level Group Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.	V181 Low-Potency Level Group Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.	Placebo Participants received a single SC 0.5 mL dose of placebo.
Overall Study STARTED	231	463	461	116
Overall Study Vaccinated at Baseline	231	461	459	115
Overall Study COMPLETED	205	430	431	106
Overall Study NOT COMPLETED	26	33	30	10

Reasons for withdrawal

Reasons for withdrawal
Measure	V181 High-Potency Level Group Participants received a single 0.5 mL subcutaneous (SC) dose of V181 High-Potency vaccine.	V181 Mid-Potency Level Group Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.	V181 Low-Potency Level Group Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.	Placebo Participants received a single SC 0.5 mL dose of placebo.
Overall Study Death	0	0	1	0
Overall Study Lost to Follow-up	22	20	20	7
Overall Study Randomized By Mistake Without Study Treatment	0	2	1	0
Overall Study Withdrawal by Subject	4	11	7	3
Overall Study Participant left the country	0	0	1	0

Baseline Characteristics

Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V181 High-Potency Level Group n=231 Participants Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.	V181 Mid-Potency Level Group n=463 Participants Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.	V181 Low-Potency Level Group n=461 Participants Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.	Placebo n=116 Participants Participants received a single SC 0.5 mL dose of placebo.	Total n=1271 Participants Total of all reporting groups
Age, Continuous	33.8 Years STANDARD_DEVIATION 9.5 • n=5 Participants	33.1 Years STANDARD_DEVIATION 9.8 • n=7 Participants	33.3 Years STANDARD_DEVIATION 9.3 • n=5 Participants	33.2 Years STANDARD_DEVIATION 9.1 • n=4 Participants	33.3 Years STANDARD_DEVIATION 9.5 • n=21 Participants
Sex/Gender, Customized Female	129 Participants n=5 Participants	265 Participants n=7 Participants	262 Participants n=5 Participants	59 Participants n=4 Participants	715 Participants n=21 Participants
Sex/Gender, Customized Male	102 Participants n=5 Participants	198 Participants n=7 Participants	198 Participants n=5 Participants	57 Participants n=4 Participants	555 Participants n=21 Participants
Sex/Gender, Customized Undifferentiated	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=5 Participants	51 Participants n=7 Participants	55 Participants n=5 Participants	20 Participants n=4 Participants	157 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	195 Participants n=5 Participants	396 Participants n=7 Participants	389 Participants n=5 Participants	94 Participants n=4 Participants	1074 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants	2 Participants n=4 Participants	40 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	32 Participants n=7 Participants	33 Participants n=5 Participants	6 Participants n=4 Participants	86 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	9 Participants n=4 Participants	40 Participants n=21 Participants
Race (NIH/OMB) White	207 Participants n=5 Participants	406 Participants n=7 Participants	400 Participants n=5 Participants	100 Participants n=4 Participants	1113 Participants n=21 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	1 Participants n=4 Participants	23 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: Day 28 post-vaccination

Population: The population analyzed was all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. These deviations include participant was seropositive at baseline as assessed by VRNT and missing serology results.

Outcome measures

Outcome measures
Measure	V181 High-Potency Level Group n=178 Participants Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.	V181 Mid-Potency Level Group n=377 Participants Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.	V181 Low-Potency Level Group n=380 Participants Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.	Placebo n=99 Participants Participants received a single SC 0.5 mL dose of placebo.
Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT) DENV1 Serotype	326.31 Titer Interval 256.52 to 415.08	261.10 Titer Interval 220.9 to 308.61	184.85 Titer Interval 153.89 to 222.03	10.33 Titer Interval 8.79 to 12.14
Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT) DENV2 Serotype	815.79 Titer Interval 674.69 to 986.4	766.98 Titer Interval 683.66 to 860.45	854.59 Titer Interval 755.07 to 967.22	7.50 Titer Interval 7.5 to 7.5
Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT) DENV3 Serotype	203.04 Titer Interval 162.87 to 253.12	135.19 Titer Interval 115.7 to 157.97	94.69 Titer Interval 78.92 to 113.61	7.20 Titer Interval 6.11 to 8.48
Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT) DENV4 Serotype	102.13 Titer Interval 77.08 to 135.33	68.33 Titer Interval 55.8 to 83.67	64.43 Titer Interval 52.42 to 79.19	6.50 Titer Interval 6.5 to 6.5

PRIMARY outcome

Timeframe: Up to 28 days post-vaccination

Population: The population analyzed was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received.

An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator.

Outcome measures

Outcome measures
Measure	V181 High-Potency Level Group n=231 Participants Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.	V181 Mid-Potency Level Group n=461 Participants Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.	V181 Low-Potency Level Group n=459 Participants Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.	Placebo n=115 Participants Participants received a single SC 0.5 mL dose of placebo.
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 5 days post-vaccination

Population: The population analyzed was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received.

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs include pain, erythema (redness), and swelling.

Outcome measures

Outcome measures
Measure	V181 High-Potency Level Group n=231 Participants Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.	V181 Mid-Potency Level Group n=461 Participants Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.	V181 Low-Potency Level Group n=459 Participants Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.	Placebo n=115 Participants Participants received a single SC 0.5 mL dose of placebo.
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Injection site erythema	35.5 Percentage of participants	21.7 Percentage of participants	15.0 Percentage of participants	1.7 Percentage of participants
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Injection site pain	34.2 Percentage of participants	19.7 Percentage of participants	13.5 Percentage of participants	14.8 Percentage of participants
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Injection site swelling	10.0 Percentage of participants	5.4 Percentage of participants	2.4 Percentage of participants	2.6 Percentage of participants

SECONDARY outcome

Timeframe: Up to 28 days post-vaccination

Population: The population analyzed was all randomized participants who received at least 1 dose of study intervention according to the study intervention they received.

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include rash, headache, fatigue (tiredness), pyrexia (oral temperature ≥100.4 °F or 38.0 °C), myalgia (muscle pain), and arthralgia (joint pain).

Outcome measures

Outcome measures
Measure	V181 High-Potency Level Group n=231 Participants Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.	V181 Mid-Potency Level Group n=461 Participants Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.	V181 Low-Potency Level Group n=459 Participants Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.	Placebo n=115 Participants Participants received a single SC 0.5 mL dose of placebo.
Percentage of Participants With Solicited Systemic AEs Myalgia	32.0 Percentage of participants	26.5 Percentage of participants	24.0 Percentage of participants	18.3 Percentage of participants
Percentage of Participants With Solicited Systemic AEs Fatigue	52.8 Percentage of participants	48.6 Percentage of participants	44.0 Percentage of participants	33.9 Percentage of participants
Percentage of Participants With Solicited Systemic AEs Pyrexia	10.8 Percentage of participants	7.6 Percentage of participants	5.7 Percentage of participants	0.9 Percentage of participants
Percentage of Participants With Solicited Systemic AEs Arthralgia	21.2 Percentage of participants	12.6 Percentage of participants	13.1 Percentage of participants	7.8 Percentage of participants
Percentage of Participants With Solicited Systemic AEs Headache	54.5 Percentage of participants	49.9 Percentage of participants	46.2 Percentage of participants	47.0 Percentage of participants
Percentage of Participants With Solicited Systemic AEs Rash	55.8 Percentage of participants	64.0 Percentage of participants	68.6 Percentage of participants	8.7 Percentage of participants

Adverse Events

V181 High-Potency Level

Serious events: 8 serious events

Other events: 200 other events

Deaths: 0 deaths

V181 Mid-Potency Level

Serious events: 9 serious events

Other events: 402 other events

Deaths: 0 deaths

V181 Low-Potency Level

Serious events: 12 serious events

Other events: 406 other events

Deaths: 1 deaths

Placebo

Serious events: 6 serious events

Other events: 79 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V181 High-Potency Level n=231 participants at risk Participants received a single 0.5 mL SC dose of V181 High-Potency vaccine.	V181 Mid-Potency Level n=461 participants at risk Participants received a single 0.5 mL SC dose of V181 Mid-Potency vaccine.	V181 Low-Potency Level n=459 participants at risk Participants received a single 0.5 mL SC dose of V181 Low-Potency vaccine.	Placebo n=115 participants at risk Participants received a single 0.5 mL SC dose of placebo
Blood and lymphatic system disorders Lymphadenopathy	1.7% 4/231 • Number of events 4 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	2.6% 12/461 • Number of events 13 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	5.2% 24/459 • Number of events 24 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	0.00% 0/115 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
Gastrointestinal disorders Nausea	5.6% 13/231 • Number of events 15 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	2.0% 9/461 • Number of events 12 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	3.3% 15/459 • Number of events 15 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	2.6% 3/115 • Number of events 3 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
General disorders Fatigue	52.8% 122/231 • Number of events 125 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	48.6% 224/461 • Number of events 231 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	44.0% 202/459 • Number of events 212 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	33.9% 39/115 • Number of events 43 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
General disorders Injection site erythema	36.8% 85/231 • Number of events 89 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	23.2% 107/461 • Number of events 108 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	16.6% 76/459 • Number of events 76 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	1.7% 2/115 • Number of events 2 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
General disorders Injection site pain	34.6% 80/231 • Number of events 80 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	19.7% 91/461 • Number of events 92 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	15.0% 69/459 • Number of events 69 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	15.7% 18/115 • Number of events 18 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
General disorders Injection site swelling	10.0% 23/231 • Number of events 23 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	5.4% 25/461 • Number of events 25 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	2.6% 12/459 • Number of events 12 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	2.6% 3/115 • Number of events 3 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
General disorders Pyrexia	10.8% 25/231 • Number of events 25 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	7.6% 35/461 • Number of events 35 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	5.7% 26/459 • Number of events 26 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	0.87% 1/115 • Number of events 1 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
Infections and infestations Nasopharyngitis	5.2% 12/231 • Number of events 12 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	6.7% 31/461 • Number of events 31 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	3.3% 15/459 • Number of events 15 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	3.5% 4/115 • Number of events 4 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
Musculoskeletal and connective tissue disorders Arthralgia	21.2% 49/231 • Number of events 50 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	12.6% 58/461 • Number of events 58 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	13.1% 60/459 • Number of events 60 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	7.8% 9/115 • Number of events 9 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
Musculoskeletal and connective tissue disorders Myalgia	32.0% 74/231 • Number of events 75 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	26.5% 122/461 • Number of events 125 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	24.0% 110/459 • Number of events 112 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	18.3% 21/115 • Number of events 21 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
Nervous system disorders Headache	54.5% 126/231 • Number of events 131 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	49.9% 230/461 • Number of events 240 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	46.2% 212/459 • Number of events 230 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	47.0% 54/115 • Number of events 56 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.2% 12/231 • Number of events 12 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	5.6% 26/461 • Number of events 26 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	5.4% 25/459 • Number of events 26 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	4.3% 5/115 • Number of events 5 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received
Skin and subcutaneous tissue disorders Rash	55.8% 129/231 • Number of events 131 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	64.0% 295/461 • Number of events 295 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	68.6% 315/459 • Number of events 315 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received	8.7% 10/115 • Number of events 10 • All-cause Mortality: Randomization up to 12 months post-vaccination; Serious Adverse Events: Vaccination up to 12 months post-vaccination; Non-Serious Adverse Events: Vaccination up to 28 Days post-vaccination All-cause Mortality: randomized participants; Adverse Events: randomized participants who received at least 1 dose of study intervention according to the study intervention they received

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