Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911) (NCT NCT05158140)

Results Overview

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

850 participants

Primary outcome timeframe

Up to Day 7 After Any Vaccination (Up to Study Day 37)

Results posted on

2025-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	V114 Concomitant With mRNA-1273 (V114 Concomitant) Participants received a single 0.5 mL IM vaccination of V114 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V114 on Day 30.	V114 Nonconcomitant With mRNA-1273 (V114 Nonconcomitant) Participants received single 0.5 mL IM injection of placebo for V114 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V114 on Day 30.
Overall Study STARTED	214	212	214	210
Overall Study Received Any Vaccination	214	211	210	208
Overall Study COMPLETED	208	199	203	198
Overall Study NOT COMPLETED	6	13	11	12

Reasons for withdrawal

Reasons for withdrawal
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	V114 Concomitant With mRNA-1273 (V114 Concomitant) Participants received a single 0.5 mL IM vaccination of V114 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V114 on Day 30.	V114 Nonconcomitant With mRNA-1273 (V114 Nonconcomitant) Participants received single 0.5 mL IM injection of placebo for V114 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V114 on Day 30.
Overall Study Death	0	0	0	1
Overall Study Lost to Follow-up	3	6	4	3
Overall Study Randomized By Mistake Without Study Treatment	0	0	4	1
Overall Study Withdrawal by Subject	3	7	3	7

Baseline Characteristics

Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=214 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=212 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	V114 Concomitant With mRNA-1273 (V114 Concomitant) n=214 Participants Participants received a single 0.5 mL IM vaccination of V114 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V114 on Day 30.	V114 Nonconcomitant With mRNA-1273 (V114 Nonconcomitant) n=210 Participants Participants received single 0.5 mL IM injection of placebo for V114 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V114 on Day 30.	Total n=850 Participants Total of all reporting groups
Age, Continuous	60.5 Years STANDARD_DEVIATION 8.1 • n=5 Participants	60.4 Years STANDARD_DEVIATION 8.4 • n=7 Participants	60.4 Years STANDARD_DEVIATION 7.8 • n=5 Participants	60.3 Years STANDARD_DEVIATION 8.1 • n=4 Participants	60.4 Years STANDARD_DEVIATION 8.1 • n=21 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	131 Participants n=7 Participants	113 Participants n=5 Participants	130 Participants n=4 Participants	481 Participants n=21 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	81 Participants n=7 Participants	101 Participants n=5 Participants	80 Participants n=4 Participants	369 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	87 Participants n=5 Participants	98 Participants n=7 Participants	90 Participants n=5 Participants	93 Participants n=4 Participants	368 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	127 Participants n=5 Participants	112 Participants n=7 Participants	124 Participants n=5 Participants	116 Participants n=4 Participants	479 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	4 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	41 Participants n=5 Participants	33 Participants n=7 Participants	36 Participants n=5 Participants	40 Participants n=4 Participants	150 Participants n=21 Participants
Race (NIH/OMB) White	164 Participants n=5 Participants	173 Participants n=7 Participants	167 Participants n=5 Participants	159 Participants n=4 Participants	663 Participants n=21 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	16 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 Day 7 After Any Vaccination (Up to Study Day 37)

Population: All randomized participants who received 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=214 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=211 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 Injection site erythema	18.7 Percentage of Participants	14.7 Percentage of Participants	—
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 Injection site pain	74.8 Percentage of Participants	74.4 Percentage of Participants	—
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 Injection site swelling	23.4 Percentage of Participants	26.5 Percentage of Participants	—
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 Lymphadenopathy	17.3 Percentage of Participants	25.1 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to Day 7 After Any Vaccination (Up to Study Day 37)

Population: All randomized participants who received 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=209 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=208 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 Injection site erythema	15.3 Percentage of Participants	16.3 Percentage of Participants	—
Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 Injection site pain	70.8 Percentage of Participants	76.9 Percentage of Participants	—
Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 Injection site swelling	20.6 Percentage of Participants	29.3 Percentage of Participants	—
Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 Lymphadenopathy	17.7 Percentage of Participants	25.5 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to Day 7 After Any Vaccination (Up to Study Day 37)

Population: All randomized participants who received 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273.

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. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=214 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=211 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 Arthralgia	15.4 Percentage of Participants	17.5 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 Chills	18.7 Percentage of Participants	17.5 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 Fatigue	40.7 Percentage of Participants	36.5 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 Headache	29.0 Percentage of Participants	34.1 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 Myalgia	18.7 Percentage of Participants	24.6 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 Nausea	10.7 Percentage of Participants	13.3 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 Vomiting	3.7 Percentage of Participants	2.4 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to Day 7 After Any Vaccination (Up to Study Day 37)

Population: All randomized participants who received 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273. One participant in the V114 Concomitant Group received 2 doses of mRNA-1273 in error and was excluded from the safety population per statistical analysis plan.

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. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=209 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=208 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 Headache	29.2 Percentage of Participants	38.0 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 Arthralgia	16.7 Percentage of Participants	18.8 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 Chills	18.7 Percentage of Participants	18.8 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 Fatigue	41.1 Percentage of Participants	46.6 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 Myalgia	21.5 Percentage of Participants	26.9 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 Nausea	10.0 Percentage of Participants	15.4 Percentage of Participants	—
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 Vomiting	1.4 Percentage of Participants	2.4 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to Month 6

Population: All randomized participants who received 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273.

Serious adverse events (SAEs) are 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 in offspring of a participant, or other important medical events. V110 vaccine-related SAEs as determined by investigator are summarized.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=214 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=211 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Percentage of Participants With Vaccine-Related Serious AEs (SAEs) Among Participants Administered V110	0.0 Percentage of Participants	0.0 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to Month 6

Population: All randomized participants who received 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273. One participant in the V114 Concomitant Group received 2 doses of mRNA-1273 in error and was excluded from the safety population per statistical analysis plan.

SAEs are 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 in offspring of a participant, or other important medical events. V114 vaccine-related SAEs as determined by investigator are summarized.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=209 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=208 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Percentage of Participants With Vaccine-Related SAEs Among Participants Administered V114	0.0 Percentage of Participants	0.0 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to 30 days postvaccination with V110 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively)

Population: All randomized participants who received 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with non-missing OPA serology data for the respective serotype.

Serotype-specific OPA GMTs for 14 of the serotypes contained in V110 were determined using a multiplexed opsonophagocytic assay (MOPA) at 30 days postvaccination with V110. The within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=214 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=211 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 1	236.0 Titers Interval 177.0 to 314.6	235.5 Titers Interval 188.4 to 341.1	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 3	174.3 Titers Interval 138.6 to 219.2	284.0 Titers Interval 224.1 to 359.9	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 4	1384.5 Titers Interval 1110.7 to 1725.9	1704.4 Titers Interval 1370.6 to 2119.5	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 5	423.4 Titers Interval 324.9 to 551.7	376.3 Titers Interval 282.6 to 501.2	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 6B	1336.7 Titers Interval 1038.2 to 1721.0	1326.8 Titers Interval 1016.7 to 1731.4	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 7F	2614.4 Titers Interval 2123.8 to 3218.4	2420.2 Titers Interval 1919.6 to 3051.3	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 9V	1651.1 Titers Interval 1352.0 to 2016.4	1809.2 Titers Interval 1502.2 to 2179.0	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 14	3048.3 Titers Interval 2429.0 to 3825.5	2618.4 Titers Interval 2078.8 to 3298.1	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 18C	1592.9 Titers Interval 1281.0 to 1980.7	2033.7 Titers Interval 1639.6 to 2522.5	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 19A	2135.7 Titers Interval 1761.7 to 2589.2	2626.1 Titers Interval 2139.6 to 3223.2	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 19F	1379.9 Titers Interval 1144.4 to 1663.9	1532.6 Titers Interval 1250.5 to 1878.5	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 22F	2023.0 Titers Interval 1559.4 to 2624.5	2178.4 Titers Interval 1630.9 to 2909.9	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 23F	739.0 Titers Interval 559.4 to 976.3	839.9 Titers Interval 639.5 to 1103.1	—
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 Serotype 33F	10089.0 Titers Interval 7799.0 to 13051.4	10909.2 Titers Interval 8634.0 to 13783.9	—

PRIMARY outcome

Timeframe: Up to 30 days postvaccination with V114 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively)

Population: All randomized participants who received 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with non-missing OPA serology data for the respective serotype.

Serotype-specific OPA GMTs for 15 of the serotypes contained in V114 were determined using a MOPA at 30 days postvaccination with V114. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=210 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=208 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Serotype-specific OPA GMT in Participants Administered V114 Serotype 1	208.3 Titers Interval 160.8 to 269.9	265.6 Titers Interval 203.4 to 346.7	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 3	237.5 Titers Interval 197.5 to 285.6	338.4 Titers Interval 275.3 to 416.0	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 4	1586.0 Titers Interval 1296.5 to 1940.2	1758.6 Titers Interval 1419.4 to 2178.8	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 5	447.0 Titers Interval 341.7 to 584.8	505.5 Titers Interval 382.7 to 667.8	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 6A	4345.3 Titers Interval 3490.0 to 5410.1	5787.1 Titers Interval 4468.4 to 7495.0	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 6B	3655.5 Titers Interval 2939.1 to 4546.6	4992.9 Titers Interval 3896.2 to 6398.2	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 7F	3465.7 Titers Interval 2858.7 to 4201.6	3283.0 Titers Interval 2664.3 to 4045.4	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 9V	1730.3 Titers Interval 1432.7 to 2089.8	2026.6 Titers Interval 1651.0 to 2487.5	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 14	2487.2 Titers Interval 2026.1 to 3053.2	2460.8 Titers Interval 2018.4 to 3000.3	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 18C	3144.5 Titers Interval 2597.3 to 3806.8	3183.5 Titers Interval 2587.9 to 3916.2	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 19A	3214.3 Titers Interval 2735.5 to 3776.9	4037.4 Titers Interval 3234.4 to 5039.8	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 19F	1742.0 Titers Interval 1440.1 to 2107.2	1950.1 Titers Interval 1592.9 to 2387.4	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 22F	2282.7 Titers Interval 1804.7 to 2887.3	2670.6 Titers Interval 2062.6 to 3457.9	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 23F	2326.3 Titers Interval 1831.2 to 2955.2	2212.0 Titers Interval 1685.3 to 2903.3	—
Serotype-specific OPA GMT in Participants Administered V114 Serotype 33F	6788.5 Titers Interval 5312.9 to 8673.9	9339.7 Titers Interval 7330.9 to 11899.0	—

PRIMARY outcome

Timeframe: Up to 30 days postvaccination with mRNA-1273 (Study Day 30)

Population: All randomized participants who received 1 dose of either V110 or V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results and with available bAb data. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the vaccinations at the first visit (mRNA-1273 and placebo).

Sera from participants were used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein at 30 days post vaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo).

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=197 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=196 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant n=382 Participants Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
SARS-CoV-2-specific Binding Antibody (bAb) GMT in Participants Administered Either V110 or V114	824118.4 Titers Interval 717446.4 to 946650.6	861746.4 Titers Interval 756496.4 to 981639.8	1102295.7 Titers Interval 1003694.1 to 1210583.7

SECONDARY outcome

Timeframe: Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)

Population: All randomized participants receiving 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.

Serotype-specific OPA for 14 of the serotypes contained in V110 was determined using a MOPA. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=214 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=211 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 1	24.8 Ratio Interval 18.3 to 33.7	24.2 Ratio Interval 17.8 to 33.0	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 3	7.1 Ratio Interval 5.7 to 8.9	11.6 Ratio Interval 9.1 to 14.8	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 4	12.8 Ratio Interval 9.5 to 17.3	15.7 Ratio Interval 11.5 to 21.3	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 5	15.1 Ratio Interval 11.5 to 19.9	13.8 Ratio Interval 10.4 to 18.2	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 6B	8.2 Ratio Interval 6.0 to 11.2	8.6 Ratio Interval 6.3 to 11.6	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 7F	14.5 Ratio Interval 11.0 to 19.2	14.8 Ratio Interval 10.8 to 20.2	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 9V	4.3 Ratio Interval 3.4 to 5.4	5.3 Ratio Interval 4.2 to 6.7	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 14	6.0 Ratio Interval 4.6 to 7.7	7.0 Ratio Interval 5.3 to 9.2	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 18C	10.2 Ratio Interval 8.1 to 12.9	10.9 Ratio Interval 8.5 to 13.9	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 19A	7.8 Ratio Interval 6.1 to 9.9	8.7 Ratio Interval 6.7 to 11.3	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 19F	6.9 Ratio Interval 5.3 to 8.8	6.7 Ratio Interval 5.4 to 8.4	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 22F	25.6 Ratio Interval 16.8 to 39.0	30.8 Ratio Interval 20.1 to 47.1	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 23F	4.7 Ratio Interval 3.5 to 6.5	6.2 Ratio Interval 4.6 to 8.5	—
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 Serotype 33F	12.2 Ratio Interval 8.9 to 16.7	16.9 Ratio Interval 11.7 to 24.3	—

SECONDARY outcome

Timeframe: Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)

Population: All randomized participants receiving 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.

Serotype-specific OPA for all 15 of the serotypes contained in V114 were determined using a MOPA. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=210 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=208 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 22F	40.7 Ratio Interval 25.7 to 64.6	43.9 Ratio Interval 27.4 to 70.2	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 1	17.3 Ratio Interval 12.8 to 23.5	24.5 Ratio Interval 17.8 to 33.6	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 3	9.0 Ratio Interval 7.0 to 11.5	14.5 Ratio Interval 11.2 to 18.8	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 4	13.3 Ratio Interval 9.4 to 18.6	20.6 Ratio Interval 14.8 to 28.8	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 5	14.7 Ratio Interval 11.2 to 19.4	18.7 Ratio Interval 13.9 to 25.2	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 6A	12.7 Ratio Interval 9.9 to 16.4	23.0 Ratio Interval 17.0 to 31.0	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 6B	19.6 Ratio Interval 14.0 to 27.3	28.4 Ratio Interval 19.8 to 40.9	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 7F	17.6 Ratio Interval 12.7 to 24.3	14.9 Ratio Interval 10.8 to 20.4	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 9V	4.7 Ratio Interval 3.7 to 5.9	5.2 Ratio Interval 4.1 to 6.5	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 14	4.8 Ratio Interval 3.6 to 6.4	6.3 Ratio Interval 4.7 to 8.3	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 18C	16.6 Ratio Interval 12.4 to 22.3	17.6 Ratio Interval 13.5 to 22.9	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 19A	9.5 Ratio Interval 7.1 to 12.5	15.2 Ratio Interval 11.2 to 20.7	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 19F	8.6 Ratio Interval 6.6 to 11.2	9.8 Ratio Interval 7.5 to 12.8	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 23F	13.9 Ratio Interval 10.1 to 19.1	17.0 Ratio Interval 12.1 to 23.9	—
Serotype-specific OPA GMFR in Participants Administered V114 Serotype 33F	7.9 Ratio Interval 5.8 to 10.9	12.4 Ratio Interval 8.7 to 17.7	—

SECONDARY outcome

Timeframe: Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively)

Population: All randomized participants who received 1 dose of either V110 or V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results and with available baseline and post-vaccination bAb data. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same vaccinations at the first visit (mRNA-1273 and placebo).

Sera from participants was used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo).

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=196 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=195 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant n=379 Participants Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
SARS-CoV-2-specific Binding Antibody (bAb) GMFR in Participants Administered Either V110 or V114	8.6 Ratio Interval 6.7 to 11.0	8.1 Ratio Interval 6.4 to 10.2	9.1 Ratio Interval 7.7 to 10.8

SECONDARY outcome

Timeframe: Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)

Population: All randomized participants receiving 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.

Serotype-specific OPA for 14 of the serotypes contained in V110 was determined using a MOPA. The percentage of participants who achieved a ≥4-fold rise in OPA titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=214 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=211 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 18C	66.7 Percentage of Participants Interval 59.3 to 73.5	69.9 Percentage of Participants Interval 62.5 to 76.7	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 1	76.0 Percentage of Participants Interval 69.0 to 82.1	75.1 Percentage of Participants Interval 68.0 to 81.4	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 3	66.9 Percentage of Participants Interval 58.8 to 74.3	72.5 Percentage of Participants Interval 64.8 to 79.4	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 4	66.3 Percentage of Participants Interval 58.6 to 73.4	68.2 Percentage of Participants Interval 60.2 to 75.4	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 5	75.0 Percentage of Participants Interval 68.0 to 81.1	69.9 Percentage of Participants Interval 62.5 to 76.6	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 6B	55.8 Percentage of Participants Interval 48.1 to 63.4	56.7 Percentage of Participants Interval 48.8 to 64.4	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 7F	71.2 Percentage of Participants Interval 63.7 to 77.9	66.7 Percentage of Participants Interval 58.8 to 73.9	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 9V	47.1 Percentage of Participants Interval 39.4 to 54.9	51.9 Percentage of Participants Interval 43.8 to 59.8	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 14	49.4 Percentage of Participants Interval 41.6 to 57.2	52.4 Percentage of Participants Interval 44.5 to 60.1	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 19A	61.5 Percentage of Participants Interval 53.8 to 68.8	62.1 Percentage of Participants Interval 54.1 to 69.6	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 19F	62.3 Percentage of Participants Interval 54.4 to 69.8	60.3 Percentage of Participants Interval 52.1 to 68.0	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 22F	68.5 Percentage of Participants Interval 60.3 to 75.9	66.0 Percentage of Participants Interval 57.8 to 73.5	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 23F	44.3 Percentage of Participants Interval 36.6 to 52.2	53.9 Percentage of Participants Interval 45.7 to 61.9	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 Serotype 33F	67.3 Percentage of Participants Interval 53.5 to 74.4	67.9 Percentage of Participants Interval 60.0 to 75.2	—

SECONDARY outcome

Timeframe: Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)

Population: All randomized participants receiving 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.

Serotype-specific OPA for all 15 of the serotypes in V114 were determined using a MOPA. The percentage of participants who achieved a ≥4-fold rise in OPA titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=210 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=208 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 1	72.7 Percentage of Participants Interval 65.5 to 79.2	73.4 Percentage of Participants Interval 66.2 to 79.8	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 3	65.2 Percentage of Participants Interval 57.3 to 72.5	79.3 Percentage of Participants Interval 72.0 to 85.5	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 4	68.9 Percentage of Participants Interval 61.2 to 75.9	73.2 Percentage of Participants Interval 65.7 to 79.8	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 5	70.5 Percentage of Participants Interval 63.3 to 77.0	73.2 Percentage of Participants Interval 66.1 to 79.5	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 6A	75.9 Percentage of Participants Interval 68.6 to 82.3	82.6 Percentage of Participants Interval 75.5 to 88.3	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 6B	75.6 Percentage of Participants Interval 68.3 to 82.0	76.5 Percentage of Participants Interval 68.9 to 82.9	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 7F	67.8 Percentage of Participants Interval 60.4 to 74.6	65.2 Percentage of Participants Interval 57.4 to 72.5	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 9V	48.6 Percentage of Participants Interval 41.0 to 56.2	53.2 Percentage of Participants Interval 45.1 to 61.1	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 14	45.5 Percentage of Participants Interval 38.0 to 53.1	51.8 Percentage of Participants Interval 43.9 to 59.6	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 18C	72.9 Percentage of Participants Interval 65.7 to 79.3	75.4 Percentage of Participants Interval 68.2 to 81.8	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 19A	63.6 Percentage of Participants Interval 55.7 to 71.0	68.6 Percentage of Participants Interval 60.7 to 75.8	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 19F	66.1 Percentage of Participants Interval 58.4 to 73.2	67.7 Percentage of Participants Interval 59.8 to 75.0	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 22F	69.1 Percentage of Participants Interval 61.1 to 76.3	72.5 Percentage of Participants Interval 64.4 to 79.7	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 23F	65.0 Percentage of Participants Interval 57.2 to 72.3	70.1 Percentage of Participants Interval 62.2 to 77.2	—
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 Serotype 33F	56.2 Percentage of Participants Interval 48.2 to 63.9	63.6 Percentage of Participants Interval 55.7 to 71.0	—

SECONDARY outcome

Timeframe: Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively)

Population: All randomized participants who received 1 dose of either V110 or V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results and with available baseline and post-vaccination bAb data. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same vaccinations at the first visit (mRNA-1273 and placebo).

Sera from participants was used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein. The percentage of participants who achieved a ≥4-fold rise in bAb titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo).

Outcome measures

Outcome measures
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=196 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=195 Participants Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	Combined V110/V114 Nonconcomitant n=379 Participants Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273.
Percentage of Participants With ≥4 Fold Rise From Baseline in SARS-CoV-2-specific bAb Response	55.1 Percentage of Participants Interval 47.9 to 62.2	52.3 Percentage of Participants Interval 45.1 to 59.5	55.9 Percentage of Participants Interval 50.8 to 61.0

Adverse Events

V110 Concomitant With mRNA-1273 (V110 Concomitant)

Serious events: 2 serious events

Other events: 171 other events

Deaths: 0 deaths

V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant)

Serious events: 2 serious events

Other events: 170 other events

Deaths: 0 deaths

V114 Concomitant With mRNA-1273 (V114 Concomitant)

Serious events: 6 serious events

Other events: 163 other events

Deaths: 0 deaths

V114 Nonconcomitant With mRNA-1273 (V114 Nonconcomitant)

Serious events: 4 serious events

Other events: 172 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V110 Concomitant With mRNA-1273 (V110 Concomitant) n=214 participants at risk Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.	V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) n=211 participants at risk Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30.	V114 Concomitant With mRNA-1273 (V114 Concomitant) n=209 participants at risk Participants received a single 0.5 mL IM vaccination of V114 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V114 on Day 30.	V114 Nonconcomitant With mRNA-1273 (V114 Nonconcomitant) n=208 participants at risk Participants received single 0.5 mL IM injection of placebo for V114 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V114 on Day 30.
Blood and lymphatic system disorders Lymphadenopathy	17.3% 37/214 • Number of events 37 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	25.1% 53/211 • Number of events 53 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	17.7% 37/209 • Number of events 37 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	25.5% 53/208 • Number of events 54 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.
Gastrointestinal disorders Nausea	10.7% 23/214 • Number of events 23 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	13.3% 28/211 • Number of events 28 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	10.5% 22/209 • Number of events 22 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	15.4% 32/208 • Number of events 32 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.
General disorders Chills	18.7% 40/214 • Number of events 40 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	17.5% 37/211 • Number of events 37 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	19.1% 40/209 • Number of events 40 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	18.8% 39/208 • Number of events 39 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.
General disorders Fatigue	41.1% 88/214 • Number of events 89 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	37.0% 78/211 • Number of events 78 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	41.1% 86/209 • Number of events 87 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	47.6% 99/208 • Number of events 100 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.
General disorders Injection site erythema	18.7% 40/214 • Number of events 40 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	14.7% 31/211 • Number of events 31 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	15.3% 32/209 • Number of events 32 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	17.3% 36/208 • Number of events 36 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.
General disorders Injection site pain	74.8% 160/214 • Number of events 160 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	74.4% 157/211 • Number of events 158 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	70.8% 148/209 • Number of events 148 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	76.9% 160/208 • Number of events 161 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.
General disorders Injection site swelling	23.4% 50/214 • Number of events 50 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	26.5% 56/211 • Number of events 56 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	20.6% 43/209 • Number of events 43 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	29.3% 61/208 • Number of events 61 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 33/214 • Number of events 33 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	17.5% 37/211 • Number of events 38 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	16.7% 35/209 • Number of events 35 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	19.2% 40/208 • Number of events 40 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.
Musculoskeletal and connective tissue disorders Myalgia	19.2% 41/214 • Number of events 41 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	25.1% 53/211 • Number of events 55 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	21.5% 45/209 • Number of events 45 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	26.9% 56/208 • Number of events 56 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.
Nervous system disorders Headache	30.4% 65/214 • Number of events 67 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	34.1% 72/211 • Number of events 75 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	29.7% 62/209 • Number of events 65 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.	38.0% 79/208 • Number of events 81 • Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months. All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. A coordinating investigator will be designated by mutual agreement. If publication activity is not directed by Sponsor, investigator agrees to submit all manuscripts or abstracts to Sponsor before submission, allowing Sponsor to protect proprietary information and provide comments. Authorship will be determined by mutual agreement in line with ICMJE authorship requirements.
Publication restrictions are in place

Restriction type: OTHER