Trial Outcomes & Findings for V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002) (NCT NCT03486834)

Last Updated: 2024-01-23

Results Overview

Cytomegalovirus infection (CMVi) was defined as the detection of wild-type cytomegalovirus (CMV) (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 3-dose regimen group compared to the placebo group was assessed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

2200 participants

Primary outcome timeframe

4 weeks post last vaccination (Month 7) up to ~Month 24

Results posted on

2024-01-23

Participant Flow

A total of approximately 2100 participants were planned to be enrolled with 2200 participants actually randomized.

Participant milestones

Participant milestones
Measure	V160 3-Dose Regimen Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.	V160 2-Dose Regimen Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.	Placebo Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Overall Study STARTED	733	733	734
Overall Study Treatment 1	729	729	733
Overall Study Treatment 2	680	680	679
Overall Study Treatment 3	614	631	622
Overall Study COMPLETED	614	631	622
Overall Study NOT COMPLETED	119	102	112

Reasons for withdrawal

Reasons for withdrawal
Measure	V160 3-Dose Regimen Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.	V160 2-Dose Regimen Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.	Placebo Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Overall Study Withdrawal by Subject	46	46	52
Overall Study Adverse Event	8	7	0
Overall Study Lost to Follow-up	41	24	39
Overall Study Non-compliance with Study Drug	2	2	0
Overall Study Physician Decision	5	2	3
Overall Study Pregnancy	10	12	12
Overall Study Protocol Deviation	2	3	3
Overall Study Withdrawal by Parent/Guardian	1	2	2
Overall Study Randomized but not treated	4	4	1

Baseline Characteristics

V160 2-Dose and 3-Dose Regimens in Healthy Cytomegalovirus (CMV) Seronegative Females (V160-002)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V160 3-Dose Regimen n=733 Participants Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.	V160 2-Dose Regimen n=733 Participants Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.	Placebo n=734 Participants Participants received placebo by IM injection on Day 1, Month 2, and Month 6.	Total n=2200 Participants Total of all reporting groups
Age, Continuous	26.0 Years STANDARD_DEVIATION 5.0 • n=5 Participants	26.1 Years STANDARD_DEVIATION 4.9 • n=7 Participants	25.9 Years STANDARD_DEVIATION 4.9 • n=5 Participants	26.0 Years STANDARD_DEVIATION 4.9 • n=4 Participants
Sex: Female, Male Female	733 Participants n=5 Participants	733 Participants n=7 Participants	734 Participants n=5 Participants	2200 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	144 Participants n=5 Participants	145 Participants n=7 Participants	143 Participants n=5 Participants	432 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	588 Participants n=5 Participants	585 Participants n=7 Participants	587 Participants n=5 Participants	1760 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 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
Race (NIH/OMB) Black or African American	47 Participants n=5 Participants	49 Participants n=7 Participants	43 Participants n=5 Participants	139 Participants n=4 Participants
Race (NIH/OMB) White	657 Participants n=5 Participants	652 Participants n=7 Participants	665 Participants n=5 Participants	1974 Participants n=4 Participants
Race (NIH/OMB) More than one race	23 Participants n=5 Participants	23 Participants n=7 Participants	16 Participants n=5 Participants	62 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks post last vaccination (Month 7) up to ~Month 24

Population: The analysis population included participants who were CMV seronegative at Day 1 and CMV negative by polymerase chain reaction (PCR) for nonvaccine strain virus from post Day 1 through Month 7, had received all 3 injections/vaccinations within the vaccination visit window, and did not have any deviations from protocol deemed to potentially interfere with the evaluation of efficacy or immune response to injection of V160.

Outcome measures

Outcome measures
Measure	V160 3-Dose Regimen n=556 Participants Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.	Placebo n=543 Participants Participants received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)	14 Participants	24 Participants	—

PRIMARY outcome

Timeframe: Up to 5 days after each vaccination

Population: The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received.

An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and pain.

Outcome measures

Outcome measures
Measure	V160 3-Dose Regimen n=728 Participants Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.	Placebo n=729 Participants Participants received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo n=732 Participants Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Number of Participants With Solicited Injection-site Adverse Events	683 Participants	668 Participants	249 Participants

PRIMARY outcome

Timeframe: Up to 14 days after each vaccination

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, joint pain/arthralgia, muscle pain/myalgia, and headache.

Outcome measures

Outcome measures
Measure	V160 3-Dose Regimen n=728 Participants Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.	Placebo n=729 Participants Participants received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo n=732 Participants Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Number of Participants With Solicited Systemic AEs	621 Participants	633 Participants	508 Participants

PRIMARY outcome

Timeframe: Up to 14 days after each vaccination

A serious adverse event (SAE) is an AE that 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 was determined by the investigator. Following vaccination with V160 or placebo, the number of participants with vaccine-related serious adverse events was assessed.

Outcome measures

Outcome measures
Measure	V160 3-Dose Regimen n=728 Participants Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.	Placebo n=729 Participants Participants received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo n=732 Participants Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Number of Participants With Vaccine-related Serious Adverse Events	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 weeks post last vaccination (Month 7) up to ~Month 24

Population: The analysis population included participants who were CMV seronegative at Day 1 and CMV negative by polymerase chain reaction (PCR) for nonvaccine strain virus from post Day 1 through Month 7, had received all 2 injections/vaccinations within the vaccination visit window, and did not have any deviations from protocol deemed to potentially interfere with the evaluation of efficacy or immune response to injection of V160.

CMVi is defined as detection of wild-type CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 2-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 2-dose regimen group compared to the placebo group was assessed.

Outcome measures

Outcome measures
Measure	V160 3-Dose Regimen n=546 Participants Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.	Placebo n=543 Participants Participants received placebo by IM injection on Day 1, Month 2, and Month 6.	Placebo Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group)	31 Participants	24 Participants	—

Adverse Events

V160 3-Dose Group

Serious events: 22 serious events

Other events: 697 other events

Deaths: 0 deaths

V160 2-Dose Group

Serious events: 29 serious events

Other events: 700 other events

Deaths: 0 deaths

Placebo Group

Serious events: 26 serious events

Other events: 557 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V160 3-Dose Group n=728 participants at risk Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.	V160 2-Dose Group n=729 participants at risk Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.	Placebo Group n=732 participants at risk Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
Gastrointestinal disorders Nausea	6.2% 45/728 • Number of events 50 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	7.5% 55/729 • Number of events 68 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	6.3% 46/732 • Number of events 54 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
General disorders Fatigue	62.8% 457/728 • Number of events 1128 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	63.2% 461/729 • Number of events 1077 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	48.8% 357/732 • Number of events 843 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
General disorders Injection site erythema	34.9% 254/728 • Number of events 400 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	28.5% 208/729 • Number of events 273 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	4.1% 30/732 • Number of events 39 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
General disorders Injection site pain	93.4% 680/728 • Number of events 1943 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	91.1% 664/729 • Number of events 1524 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	32.7% 239/732 • Number of events 374 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
General disorders Injection site pruritus	6.0% 44/728 • Number of events 54 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	3.6% 26/729 • Number of events 34 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	0.55% 4/732 • Number of events 5 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
General disorders Injection site swelling	34.1% 248/728 • Number of events 404 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	32.0% 233/729 • Number of events 311 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	2.9% 21/732 • Number of events 26 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
General disorders Pyrexia	10.3% 75/728 • Number of events 93 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	12.3% 90/729 • Number of events 112 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	3.7% 27/732 • Number of events 42 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
Infections and infestations Nasopharyngitis	7.3% 53/728 • Number of events 59 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	7.3% 53/729 • Number of events 56 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	5.1% 37/732 • Number of events 40 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
Musculoskeletal and connective tissue disorders Arthralgia	22.3% 162/728 • Number of events 226 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	22.2% 162/729 • Number of events 249 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	10.4% 76/732 • Number of events 121 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
Musculoskeletal and connective tissue disorders Myalgia	62.5% 455/728 • Number of events 996 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	58.2% 424/729 • Number of events 818 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	27.3% 200/732 • Number of events 336 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
Nervous system disorders Headache	59.6% 434/728 • Number of events 988 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	61.7% 450/729 • Number of events 976 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	50.3% 368/732 • Number of events 795 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.5% 62/728 • Number of events 81 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	8.9% 65/729 • Number of events 80 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.	9.4% 69/732 • Number of events 80 • All-cause mortality and serious adverse events: Up to ~Month 24; Non-serious adverse events: Up to 14 days following any vaccination. The analysis population for the serious and non-serious adverse events included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received. The all-cause mortality analysis population included all randomized participants.

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 If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
Publication restrictions are in place

Restriction type: OTHER