Trial Outcomes & Findings for COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers (NCT NCT04852978)

Results Overview

High dose - (1200 mg arms)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

295 participants

Primary outcome timeframe

56 days after first dose of vaccine

Results posted on

2025-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Vaccine Only Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Overall Study STARTED	48	28	29	28	33	31	26	35	35
Overall Study COMPLETED	41	23	24	27	26	24	22	29	32
Overall Study NOT COMPLETED	7	5	5	1	7	7	4	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Vaccine Only Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Overall Study Physician Decision	0	1	0	0	0	0	0	2	0
Overall Study Sponsor request	0	0	1	0	0	0	0	0	0
Overall Study Death	0	0	0	0	0	0	1	0	0
Overall Study Lost to Follow-up	3	2	2	0	2	4	1	2	2
Overall Study Withdrawal by Subject	4	2	2	1	5	3	2	2	1

Baseline Characteristics

COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaccine Only n=48 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV n=29 Participants REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV n=33 Participants REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=31 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	Total n=293 Participants Total of all reporting groups
Age, Customized	40.2 years STANDARD_DEVIATION 12.17 • n=5 Participants	41.8 years STANDARD_DEVIATION 13.98 • n=7 Participants	39.3 years STANDARD_DEVIATION 12.76 • n=5 Participants	39.7 years STANDARD_DEVIATION 13.50 • n=4 Participants	41.6 years STANDARD_DEVIATION 12.73 • n=21 Participants	41.1 years STANDARD_DEVIATION 11.23 • n=8 Participants	39.8 years STANDARD_DEVIATION 13.76 • n=8 Participants	43.8 years STANDARD_DEVIATION 12.99 • n=24 Participants	46.3 years STANDARD_DEVIATION 11.53 • n=42 Participants	41.6 years STANDARD_DEVIATION 12.70 • n=42 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	13 Participants n=4 Participants	17 Participants n=21 Participants	16 Participants n=8 Participants	14 Participants n=8 Participants	14 Participants n=24 Participants	19 Participants n=42 Participants	143 Participants n=42 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants	15 Participants n=4 Participants	16 Participants n=21 Participants	15 Participants n=8 Participants	12 Participants n=8 Participants	21 Participants n=24 Participants	16 Participants n=42 Participants	150 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	9 Participants n=4 Participants	16 Participants n=21 Participants	19 Participants n=8 Participants	17 Participants n=8 Participants	11 Participants n=24 Participants	12 Participants n=42 Participants	121 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	19 Participants n=7 Participants	17 Participants n=5 Participants	19 Participants n=4 Participants	17 Participants n=21 Participants	12 Participants n=8 Participants	9 Participants n=8 Participants	24 Participants n=24 Participants	23 Participants n=42 Participants	171 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	3 Participants n=42 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	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	9 Participants n=21 Participants	7 Participants n=8 Participants	7 Participants n=8 Participants	10 Participants n=24 Participants	7 Participants n=42 Participants	82 Participants n=42 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	18 Participants n=7 Participants	22 Participants n=5 Participants	18 Participants n=4 Participants	23 Participants n=21 Participants	21 Participants n=8 Participants	19 Participants n=8 Participants	24 Participants n=24 Participants	27 Participants n=42 Participants	204 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: 56 days after first dose of vaccine

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints.

High dose - (1200 mg arms)

Outcome measures

Outcome measures
Measure	Vaccine Only n=41 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=22 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to the SARS-CoV-2 S Protein in Individuals Who Received High Dose REGN10933+REGN10987 (1200 mg)	2594.9 Titer Standard Deviation 1981.5	1818.6 Titer Standard Deviation 2365.8	980.8 Titer Standard Deviation 1015.1	2576.8 Titer Standard Deviation 2736.1	—	—	—	—	—

PRIMARY outcome

Timeframe: 56 days after first dose of vaccine

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints.

Submaximal dose - (150 mg, 300 mg, 600 mg, 48 mg, and 12 mg)

Outcome measures

Outcome measures
Measure	Vaccine Only n=41 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=31 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to the SARS-CoV-2 S Protein in Individual Who Received Submaximal Dose Levels of REGN10933+REGN10987 (Less Than 1200 mg)	2594.9 Titer Standard Deviation 1981.5	780.8 Titer Standard Deviation 771.1	716.1 Titer Standard Deviation 664.9	4922.8 Titer Standard Deviation 11157.3	2422.2 Titer Standard Deviation 2882.7	1549.5 Titer Standard Deviation 4334.1	—	—	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of Vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S1-RBD protein

Outcome measures

Outcome measures
Measure	Vaccine Only n=42 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=24 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 252 Days after 1st Vaccine	3665.4 Binding Antibody Unit (BAU)/mL Standard Deviation 3141.0	3488.8 Binding Antibody Unit (BAU)/mL Standard Deviation 3126.5	3180.0 Binding Antibody Unit (BAU)/mL Standard Deviation 3171.6	3174.7 Binding Antibody Unit (BAU)/mL Standard Deviation 2840.8	1508.8 Binding Antibody Unit (BAU)/mL Standard Deviation 1831.0	1539.2 Binding Antibody Unit (BAU)/mL Standard Deviation 1681.9	2898.1 Binding Antibody Unit (BAU)/mL Standard Deviation 2674.8	4269.9 Binding Antibody Unit (BAU)/mL Standard Deviation 3316.2	3556.1 Binding Antibody Unit (BAU)/mL Standard Deviation 3122.6
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 365 Days after 1st Vaccine	2722.7 Binding Antibody Unit (BAU)/mL Standard Deviation 2680.0	3904.4 Binding Antibody Unit (BAU)/mL Standard Deviation 3036.1	2804.1 Binding Antibody Unit (BAU)/mL Standard Deviation 2533.8	3008.7 Binding Antibody Unit (BAU)/mL Standard Deviation 2609.0	2180.7 Binding Antibody Unit (BAU)/mL Standard Deviation 1934.9	2155.8 Binding Antibody Unit (BAU)/mL Standard Deviation 2369.2	2727.5 Binding Antibody Unit (BAU)/mL Standard Deviation 2632.9	3193.5 Binding Antibody Unit (BAU)/mL Standard Deviation 2890.2	3136.9 Binding Antibody Unit (BAU)/mL Standard Deviation 2864.3
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) Baseline	18.7 Binding Antibody Unit (BAU)/mL Standard Deviation 9.2	15.7 Binding Antibody Unit (BAU)/mL Standard Deviation 0.0	20.7 Binding Antibody Unit (BAU)/mL Standard Deviation 25.2	15.7 Binding Antibody Unit (BAU)/mL Standard Deviation 0.0	20.1 Binding Antibody Unit (BAU)/mL Standard Deviation 11.6	24.4 Binding Antibody Unit (BAU)/mL Standard Deviation 22.5	22.6 Binding Antibody Unit (BAU)/mL Standard Deviation 14.4	20.2 Binding Antibody Unit (BAU)/mL Standard Deviation 11.2	17.6 Binding Antibody Unit (BAU)/mL Standard Deviation 10.5
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 6 Days after 1st Vaccine	47.5 Binding Antibody Unit (BAU)/mL Standard Deviation 31.8	—	—	—	—	—	352.9 Binding Antibody Unit (BAU)/mL Standard Deviation 1590.7	—	—
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 14 Days after 1st Vaccine	1176.5 Binding Antibody Unit (BAU)/mL Standard Deviation 1758.5	884.0 Binding Antibody Unit (BAU)/mL Standard Deviation 860.0	1510.6 Binding Antibody Unit (BAU)/mL Standard Deviation 2141.5	730.4 Binding Antibody Unit (BAU)/mL Standard Deviation 963.2	638.6 Binding Antibody Unit (BAU)/mL Standard Deviation 662.1	673.7 Binding Antibody Unit (BAU)/mL Standard Deviation 871.0	1046.0 Binding Antibody Unit (BAU)/mL Standard Deviation 1726.3	1184.6 Binding Antibody Unit (BAU)/mL Standard Deviation 1716.7	902.0 Binding Antibody Unit (BAU)/mL Standard Deviation 1485.9
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 28 Days after 1st Vaccine	373.0 Binding Antibody Unit (BAU)/mL Standard Deviation 416.1	276.3 Binding Antibody Unit (BAU)/mL Standard Deviation 461.4	297.8 Binding Antibody Unit (BAU)/mL Standard Deviation 514.2	171.9 Binding Antibody Unit (BAU)/mL Standard Deviation 193.1	209.0 Binding Antibody Unit (BAU)/mL Standard Deviation 207.0	246.0 Binding Antibody Unit (BAU)/mL Standard Deviation 451.3	592.3 Binding Antibody Unit (BAU)/mL Standard Deviation 1587.1	351.0 Binding Antibody Unit (BAU)/mL Standard Deviation 566.1	259.4 Binding Antibody Unit (BAU)/mL Standard Deviation 520.4
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 42 Days after 1st Vaccine	2610.7 Binding Antibody Unit (BAU)/mL Standard Deviation 2032.3	2318.5 Binding Antibody Unit (BAU)/mL Standard Deviation 2387.2	2190.4 Binding Antibody Unit (BAU)/mL Standard Deviation 2163.5	2022.8 Binding Antibody Unit (BAU)/mL Standard Deviation 2170.3	1989.5 Binding Antibody Unit (BAU)/mL Standard Deviation 1797.0	1246.5 Binding Antibody Unit (BAU)/mL Standard Deviation 1017.9	1460.5 Binding Antibody Unit (BAU)/mL Standard Deviation 1724.8	1714.4 Binding Antibody Unit (BAU)/mL Standard Deviation 1779.3	1763.1 Binding Antibody Unit (BAU)/mL Standard Deviation 1444.0
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 56 Days after 1st Vaccine	1327.7 Binding Antibody Unit (BAU)/mL Standard Deviation 1497.7	1146.2 Binding Antibody Unit (BAU)/mL Standard Deviation 1738.7	769.1 Binding Antibody Unit (BAU)/mL Standard Deviation 836.1	845.9 Binding Antibody Unit (BAU)/mL Standard Deviation 1056.3	787.9 Binding Antibody Unit (BAU)/mL Standard Deviation 630.1	669.4 Binding Antibody Unit (BAU)/mL Standard Deviation 813.7	841.7 Binding Antibody Unit (BAU)/mL Standard Deviation 1587.0	889.6 Binding Antibody Unit (BAU)/mL Standard Deviation 1475.2	732.0 Binding Antibody Unit (BAU)/mL Standard Deviation 785.6
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 168 Days after 1st Vaccine	1825.0 Binding Antibody Unit (BAU)/mL Standard Deviation 2690.3	986.3 Binding Antibody Unit (BAU)/mL Standard Deviation 1718.1	358.8 Binding Antibody Unit (BAU)/mL Standard Deviation 610.3	1211.0 Binding Antibody Unit (BAU)/mL Standard Deviation 2194.5	1772.6 Binding Antibody Unit (BAU)/mL Standard Deviation 2353.2	871.1 Binding Antibody Unit (BAU)/mL Standard Deviation 1584.9	3053.1 Binding Antibody Unit (BAU)/mL Standard Deviation 3077.9	715.2 Binding Antibody Unit (BAU)/mL Standard Deviation 1658.4	346.2 Binding Antibody Unit (BAU)/mL Standard Deviation 888.1

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of Vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine,

Anti-S1-RBD protein. Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 28 Days after 1st Vaccine	1.7 Fold Change	2.0 Fold Change	2.6 Fold Change	1.9 Fold Change	2.7 Fold Change	1.7 Fold Change	1.4 Fold Change	2.4 Fold Change	—
Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 42 Days after 1st Vaccine	1.5 Fold Change	1.6 Fold Change	1.7 Fold Change	1.9 Fold Change	1.9 Fold Change	2.3 Fold Change	2.1 Fold Change	1.4 Fold Change	—
Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 56 Days after 1st Vaccine	1.5 Fold Change	2.0 Fold Change	1.8 Fold Change	1.7 Fold Change	2.4 Fold Change	3.0 Fold Change	2.0 Fold Change	2.3 Fold Change	—
Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 168 Days after 1st Vaccine	1.8 Fold Change	4.3 Fold Change	1.8 Fold Change	1.0 Fold Change	1.1 Fold Change	0.2 Fold Change	2.9 Fold Change	3.6 Fold Change	—
Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 6 Days after 1st Vaccine	—	—	—	—	—	3.2 Fold Change	—	—	—
Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 14 Days after 1st Vaccine	0.8 Fold Change	0.6 Fold Change	1.6 Fold Change	1.1 Fold Change	1.9 Fold Change	1.3 Fold Change	1.0 Fold Change	1.3 Fold Change	—
Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 252 Days after 1st Vaccine	1.0 Fold Change	1.4 Fold Change	1.3 Fold Change	4.2 Fold Change	3.2 Fold Change	1.3 Fold Change	0.7 Fold Change	1.0 Fold Change	—
Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 365 Days after 1st Vaccine	0.4 Fold Change	0.9 Fold Change	0.9 Fold Change	0.9 Fold Change	1.2 Fold Change	1.0 Fold Change	0.7 Fold Change	0.9 Fold Change	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of Vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S1-RBD protein. Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) Baseline	-9.8 Percent Interval -24.4 to 7.5	-2.3 Percent Interval -18.1 to 16.6	-10.1 Percent Interval -24.7 to 7.2	5.0 Percent Interval -11.6 to 24.8	13.7 Percent Interval -5.1 to 36.2	13.3 Percent Interval -5.7 to 36.1	6.0 Percent Interval -10.2 to 25.2	-4.7 Percent Interval -19.3 to 12.6	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 252 Days after 1st Vaccine	-23.2 Percent Interval -68.9 to 89.3	-49.4 Percent Interval -79.5 to 25.2	-16.9 Percent Interval -65.6 to 100.5	-59.9 Percent Interval -84.2 to 1.7	-58.1 Percent Interval -84.4 to 12.6	-23.4 Percent Interval -70.5 to 99.2	6.9 Percent Interval -55.3 to 155.8	-26.2 Percent Interval -68.6 to 73.0	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 6 Days after 1st Vaccine	—	—	—	—	—	-28.7 Percent Interval -80.7 to 163.6	—	—	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 14 Days after 1st Vaccine	-15.3 Percent Interval -54.4 to 57.1	-6.2 Percent Interval -49.9 to 75.5	-43.6 Percent Interval -69.9 to 5.5	-31.6 Percent Interval -62.6 to 25.2	-33.9 Percent Interval -64.9 to 24.7	-35.0 Percent Interval -65.5 to 22.7	5.2 Percent Interval -41.5 to 89.2	-3.2 Percent Interval -46.1 to 73.7	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 28 Days after 1st Vaccine	-37.3 Percent Interval -65.1 to 12.6	-48.6 Percent Interval -71.4 to -7.7	-52.3 Percent Interval -73.5 to -14.3	-43.6 Percent Interval -68.2 to -0.1	-51.6 Percent Interval -73.5 to -11.8	-32.5 Percent Interval -63.0 to 23.2	-24.0 Percent Interval -56.2 to 31.8	-50.9 Percent Interval -71.8 to -14.5	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 42 Days after 1st Vaccine	-28.3 Percent Interval -55.9 to 16.6	-28.3 Percent Interval -55.7 to 16.0	-29.8 Percent Interval -56.6 to 13.4	-22.3 Percent Interval -51.4 to 24.3	-53.3 Percent Interval -72.1 to -21.9	-54.6 Percent Interval -73.1 to -23.5	-39.4 Percent Interval -61.4 to -4.7	-32.6 Percent Interval -57.4 to 6.7	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 56 Days after 1st Vaccine	-31.6 Percent Interval -59.9 to 16.9	-44.7 Percent Interval -67.2 to -6.7	-41.8 Percent Interval -65.5 to -1.9	-28.9 Percent Interval -57.4 to 18.5	-59.9 Percent Interval -76.9 to -30.5	-55.1 Percent Interval -74.1 to -22.2	-41.9 Percent Interval -64.5 to -5.1	-40.9 Percent Interval -64.1 to -2.6	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 168 Days after 1st Vaccine	-49.8 Percent Interval -76.6 to 7.6	-71.8 Percent Interval -86.7 to -4.0	-47.8 Percent Interval -75.2 to 9.9	7.1 Percent Interval -49.6 to 127.2	-41.2 Percent Interval -73.1 to 28.9	66.1 Percent Interval -25.0 to 267.7	-59.3 Percent Interval -79.9 to -17.5	-72.7 Percent Interval -86.6 to -44.5	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA) 365 Days after 1st Vaccine	78.4 Percent Interval -10.0 to 253.7	0.6 Percent Interval -48.8 to 97.9	39.0 Percent Interval -27.4 to 166.2	3.0 Percent Interval -47.6 to 102.5	-19.7 Percent Interval -61.3 to 66.6	19.5 Percent Interval -40.9 to 141.7	30.4 Percent Interval -31.5 to 148.3	31.6 Percent Interval -29.8 to 146.9	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of Vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

\- Anti-S protein (Spike protein)

Outcome measures

Outcome measures
Measure	Vaccine Only n=42 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=24 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) Baseline	11.7 Binding Antibody Unit (BAU)/mL Standard Deviation 10.8	12.8 Binding Antibody Unit (BAU)/mL Standard Deviation 15.7	8.5 Binding Antibody Unit (BAU)/mL Standard Deviation 7.3	11.6 Binding Antibody Unit (BAU)/mL Standard Deviation 14.7	14.2 Binding Antibody Unit (BAU)/mL Standard Deviation 21.7	14.7 Binding Antibody Unit (BAU)/mL Standard Deviation 26.1	17.3 Binding Antibody Unit (BAU)/mL Standard Deviation 39.7	7.7 Binding Antibody Unit (BAU)/mL Standard Deviation 3.8	12.9 Binding Antibody Unit (BAU)/mL Standard Deviation 18.6
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 6 Days after 1st Vaccine	27.1 Binding Antibody Unit (BAU)/mL Standard Deviation 29.2	—	—	—	—	—	662.5 Binding Antibody Unit (BAU)/mL Standard Deviation 3155.1	—	—
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 14 Days after 1st Vaccine	1597.4 Binding Antibody Unit (BAU)/mL Standard Deviation 2367.2	1319.8 Binding Antibody Unit (BAU)/mL Standard Deviation 1020.4	1984.7 Binding Antibody Unit (BAU)/mL Standard Deviation 2708.3	1003.7 Binding Antibody Unit (BAU)/mL Standard Deviation 1102.0	1020.7 Binding Antibody Unit (BAU)/mL Standard Deviation 879.1	970.4 Binding Antibody Unit (BAU)/mL Standard Deviation 1165.0	1636.9 Binding Antibody Unit (BAU)/mL Standard Deviation 3070.8	1742.4 Binding Antibody Unit (BAU)/mL Standard Deviation 2871.0	1494.4 Binding Antibody Unit (BAU)/mL Standard Deviation 2303.0
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 28 Days after 1st Vaccine	522.1 Binding Antibody Unit (BAU)/mL Standard Deviation 466.7	400.1 Binding Antibody Unit (BAU)/mL Standard Deviation 534.2	337.5 Binding Antibody Unit (BAU)/mL Standard Deviation 386.9	246.6 Binding Antibody Unit (BAU)/mL Standard Deviation 207.4	321.4 Binding Antibody Unit (BAU)/mL Standard Deviation 309.2	343.1 Binding Antibody Unit (BAU)/mL Standard Deviation 490.0	581.7 Binding Antibody Unit (BAU)/mL Standard Deviation 1292.8	434.5 Binding Antibody Unit (BAU)/mL Standard Deviation 425.0	349.0 Binding Antibody Unit (BAU)/mL Standard Deviation 518.6
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 42 Days after 1st Vaccine	3147.1 Binding Antibody Unit (BAU)/mL Standard Deviation 2905.2	2868.6 Binding Antibody Unit (BAU)/mL Standard Deviation 2645.0	2472.4 Binding Antibody Unit (BAU)/mL Standard Deviation 2243.8	2765.6 Binding Antibody Unit (BAU)/mL Standard Deviation 3830.7	2396.0 Binding Antibody Unit (BAU)/mL Standard Deviation 1923.4	1892.7 Binding Antibody Unit (BAU)/mL Standard Deviation 1462.3	2089.8 Binding Antibody Unit (BAU)/mL Standard Deviation 2548.4	2080.7 Binding Antibody Unit (BAU)/mL Standard Deviation 1477.7	2029.1 Binding Antibody Unit (BAU)/mL Standard Deviation 1652.4
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 56 Days after 1st Vaccine	1393.0 Binding Antibody Unit (BAU)/mL Standard Deviation 1232.5	1218.0 Binding Antibody Unit (BAU)/mL Standard Deviation 1192.6	941.5 Binding Antibody Unit (BAU)/mL Standard Deviation 817.6	858.8 Binding Antibody Unit (BAU)/mL Standard Deviation 849.3	1013.9 Binding Antibody Unit (BAU)/mL Standard Deviation 818.1	813.1 Binding Antibody Unit (BAU)/mL Standard Deviation 753.4	872.3 Binding Antibody Unit (BAU)/mL Standard Deviation 1076.6	1009.6 Binding Antibody Unit (BAU)/mL Standard Deviation 1182.4	911.9 Binding Antibody Unit (BAU)/mL Standard Deviation 889.7
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 168 Days after 1st Vaccine	2060.3 Binding Antibody Unit (BAU)/mL Standard Deviation 3446.9	931.9 Binding Antibody Unit (BAU)/mL Standard Deviation 1466.0	405.6 Binding Antibody Unit (BAU)/mL Standard Deviation 568.3	1378.0 Binding Antibody Unit (BAU)/mL Standard Deviation 3168.9	1966.2 Binding Antibody Unit (BAU)/mL Standard Deviation 3280.9	1251.0 Binding Antibody Unit (BAU)/mL Standard Deviation 3206.3	2982.3 Binding Antibody Unit (BAU)/mL Standard Deviation 3720.5	702.1 Binding Antibody Unit (BAU)/mL Standard Deviation 1502.8	354.8 Binding Antibody Unit (BAU)/mL Standard Deviation 591.3
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 252 Days after 1st Vaccine	4666.6 Binding Antibody Unit (BAU)/mL Standard Deviation 5091.4	3753.9 Binding Antibody Unit (BAU)/mL Standard Deviation 3919.0	3940.5 Binding Antibody Unit (BAU)/mL Standard Deviation 5162.1	3497.8 Binding Antibody Unit (BAU)/mL Standard Deviation 3891.3	1341.3 Binding Antibody Unit (BAU)/mL Standard Deviation 1963.8	1911.1 Binding Antibody Unit (BAU)/mL Standard Deviation 3022.5	2867.2 Binding Antibody Unit (BAU)/mL Standard Deviation 3284.6	5957.8 Binding Antibody Unit (BAU)/mL Standard Deviation 5727.3	5012.0 Binding Antibody Unit (BAU)/mL Standard Deviation 5693.1
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 365 Days after 1st Vaccine	2808.8 Binding Antibody Unit (BAU)/mL Standard Deviation 2971.8	3549.5 Binding Antibody Unit (BAU)/mL Standard Deviation 2982.6	2703.2 Binding Antibody Unit (BAU)/mL Standard Deviation 2444.5	2903.6 Binding Antibody Unit (BAU)/mL Standard Deviation 3225.5	2302.4 Binding Antibody Unit (BAU)/mL Standard Deviation 3101.0	3204.6 Binding Antibody Unit (BAU)/mL Standard Deviation 4670.9	2944.1 Binding Antibody Unit (BAU)/mL Standard Deviation 3850.8	3717.2 Binding Antibody Unit (BAU)/mL Standard Deviation 4290.7	3648.0 Binding Antibody Unit (BAU)/mL Standard Deviation 4074.5

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) Baseline	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 42 Days after 1st Vaccine	1.4 Fold Change	1.6 Fold Change	1.7 Fold Change	1.6 Fold Change	1.5 Fold Change	1.5 Fold Change	1.7 Fold Change	1.9 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 56 Days after 1st Vaccine	1.5 Fold Change	1.9 Fold Change	1.9 Fold Change	1.5 Fold Change	2.0 Fold Change	2.2 Fold Change	1.7 Fold Change	2.1 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 365 Days after 1st Vaccine	0.6 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.1 Fold Change	1.3 Fold Change	0.8 Fold Change	1.0 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 6 Days after 1st Vaccine	—	—	—	—	—	0.7 Fold Change	—	—	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 14 Days after 1st Vaccine	0.8 Fold Change	0.7 Fold Change	1.5 Fold Change	1.0 Fold Change	1.8 Fold Change	0.8 Fold Change	0.8 Fold Change	1.3 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 28 Days after 1st Vaccine	1.9 Fold Change	1.9 Fold Change	2.6 Fold Change	2.0 Fold Change	2.7 Fold Change	2.1 Fold Change	1.4 Fold Change	2.8 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 168 Days after 1st Vaccine	1.5 Fold Change	2.2 Fold Change	1.6 Fold Change	0.9 Fold Change	1.1 Fold Change	0.2 Fold Change	1.6 Fold Change	2.6 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 252 Days after 1st Vaccine	0.9 Fold Change	1.1 Fold Change	1.3 Fold Change	3.1 Fold Change	3.8 Fold Change	1.2 Fold Change	0.6 Fold Change	0.9 Fold Change	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of Vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S protein Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) Baseline	0.8 Percent Interval -26.7 to 38.5	-20.2 Percent Interval -42.0 to 9.8	-8.8 Percent Interval -33.6 to 25.4	3.0 Percent Interval -24.6 to 40.6	-3.2 Percent Interval -30.2 to 34.1	2.2 Percent Interval -26.6 to 42.3	-23.1 Percent Interval -43.0 to 3.7	-5.6 Percent Interval -30.1 to 27.6	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 6 Days after 1st Vaccine	—	—	—	—	—	-2.3 Percent Interval -80.9 to 398.9	—	—	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 14 Days after 1st Vaccine	-3.7 Percent Interval -43.7 to 64.7	1.8 Percent Interval -40.9 to 75.5	-34.7 Percent Interval -62.1 to 12.5	-22.9 Percent Interval -54.4 to 30.4	-27.4 Percent Interval -58.2 to 25.9	-21.6 Percent Interval -54.8 to 36.1	10.4 Percent Interval -33.7 to 83.8	8.8 Percent Interval -34.6 to 80.7	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 28 Days after 1st Vaccine	-36.8 Percent Interval -62.2 to 5.9	-50.5 Percent Interval -70.5 to -17.1	-53.6 Percent Interval -72.3 to -22.2	-44.2 Percent Interval -66.3 to -7.6	-51.8 Percent Interval -71.6 to -18.2	-40.4 Percent Interval -64.9 to 1.2	-23.9 Percent Interval -53.1 to 23.7	-48.7 Percent Interval -68.5 to -16.4	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 42 Days after 1st Vaccine	-18.5 Percent Interval -47.2 to 25.9	-24.0 Percent Interval -50.6 to 16.7	-25.3 Percent Interval -51.3 to 14.8	-16.5 Percent Interval -45.1 to 26.9	-39.4 Percent Interval -61.7 to -4.1	-39.8 Percent Interval -62.3 to -4.1	-29.9 Percent Interval -53.2 to 5.0	-36.7 Percent Interval -58.0 to -4.5	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 56 Days after 1st Vaccine	-21.5 Percent Interval -50.8 to 25.5	-35.0 Percent Interval -58.9 to 2.7	-42.7 Percent Interval -63.7 to -9.4	-22.8 Percent Interval -50.6 to 20.8	-54.5 Percent Interval -71.9 to -26.3	-47.5 Percent Interval -67.6 to -15.0	-33.5 Percent Interval -56.7 to 2.3	-39.9 Percent Interval -61.1 to -6.9	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 168 Days after 1st Vaccine	-41.5 Percent Interval -70.7 to 16.9	-66.8 Percent Interval -83.3 to -34.2	-46.7 Percent Interval -72.9 to 4.7	11.4 Percent Interval -43.8 to 120.6	-36.9 Percent Interval -69.1 to 28.6	63.2 Percent Interval -20.7 to 235.9	-56.8 Percent Interval -77.2 to -17.8	-70.1 Percent Interval -84.3 to -42.9	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 252 Days after 1st Vaccine	-23.9 Percent Interval -68.2 to 82.1	-47.5 Percent Interval -78.1 to 25.8	-23.6 Percent Interval -67.4 to 79.1	-63.8 Percent Interval -85.3 to -11.0	-58.4 Percent Interval -84.0 to 8.4	-29.9 Percent Interval -72.1 to 76.5	18.1 Percent Interval -49.2 to 174.4	-23.9 Percent Interval -66.6 to 73.5	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgA) 365 Days after 1st Vaccine	44.4 Percent Interval -23.5 to 172.5	4.4 Percent Interval -44.3 to 95.5	11.3 Percent Interval -39.1 to 103.4	-7.6 Percent Interval -50.6 to 72.9	-17.6 Percent Interval -58.2 to 62.3	-0.0 Percent Interval -48.0 to 92.2	13.2 Percent Interval -37.7 to 105.8	26.0 Percent Interval -29.7 to 126.0	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S protein

Outcome measures

Outcome measures
Measure	Vaccine Only n=42 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=24 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) Baseline	4.5 Binding Antibody Unit (BAU)/mL Standard Deviation 3.9	8.1 Binding Antibody Unit (BAU)/mL Standard Deviation 10.4	4.4 Binding Antibody Unit (BAU)/mL Standard Deviation 2.7	3.2 Binding Antibody Unit (BAU)/mL Standard Deviation 1.2	5.9 Binding Antibody Unit (BAU)/mL Standard Deviation 6.7	59.8 Binding Antibody Unit (BAU)/mL Standard Deviation 267.1	5.1 Binding Antibody Unit (BAU)/mL Standard Deviation 5.4	3.0 Binding Antibody Unit (BAU)/mL Standard Deviation 1.4	4.0 Binding Antibody Unit (BAU)/mL Standard Deviation 3.3
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 6 Days after 1st Vaccine	4.0 Binding Antibody Unit (BAU)/mL Standard Deviation 1.8	—	—	—	—	—	624.8 Binding Antibody Unit (BAU)/mL Standard Deviation 3025.9	—	—
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 14 Days after 1st Vaccine	409.7 Binding Antibody Unit (BAU)/mL Standard Deviation 527.4	600.2 Binding Antibody Unit (BAU)/mL Standard Deviation 1399.6	205.9 Binding Antibody Unit (BAU)/mL Standard Deviation 175.8	256.3 Binding Antibody Unit (BAU)/mL Standard Deviation 298.9	1742.9 Binding Antibody Unit (BAU)/mL Standard Deviation 5319.5	497.1 Binding Antibody Unit (BAU)/mL Standard Deviation 1620.0	1059.4 Binding Antibody Unit (BAU)/mL Standard Deviation 3414.4	211.8 Binding Antibody Unit (BAU)/mL Standard Deviation 226.6	345.1 Binding Antibody Unit (BAU)/mL Standard Deviation 679.0
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 28 Days after 1st Vaccine	676.8 Binding Antibody Unit (BAU)/mL Standard Deviation 878.5	468.6 Binding Antibody Unit (BAU)/mL Standard Deviation 860.3	173.3 Binding Antibody Unit (BAU)/mL Standard Deviation 137.1	183.7 Binding Antibody Unit (BAU)/mL Standard Deviation 168.5	1450.6 Binding Antibody Unit (BAU)/mL Standard Deviation 4361.4	366.7 Binding Antibody Unit (BAU)/mL Standard Deviation 1040.5	973.5 Binding Antibody Unit (BAU)/mL Standard Deviation 3309.8	318.2 Binding Antibody Unit (BAU)/mL Standard Deviation 390.6	598.7 Binding Antibody Unit (BAU)/mL Standard Deviation 2096.6
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 42 Days after 1st Vaccine	4900.0 Binding Antibody Unit (BAU)/mL Standard Deviation 3970.8	3814.3 Binding Antibody Unit (BAU)/mL Standard Deviation 3083.2	2769.7 Binding Antibody Unit (BAU)/mL Standard Deviation 2535.4	2816.7 Binding Antibody Unit (BAU)/mL Standard Deviation 2858.9	5074.9 Binding Antibody Unit (BAU)/mL Standard Deviation 6044.3	2179.8 Binding Antibody Unit (BAU)/mL Standard Deviation 928.5	3968.7 Binding Antibody Unit (BAU)/mL Standard Deviation 3806.8	2797.7 Binding Antibody Unit (BAU)/mL Standard Deviation 1787.2	2852.9 Binding Antibody Unit (BAU)/mL Standard Deviation 2450.6
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 56 Days after 1st Vaccine	3459.1 Binding Antibody Unit (BAU)/mL Standard Deviation 3498.4	3737.3 Binding Antibody Unit (BAU)/mL Standard Deviation 4638.6	1841.8 Binding Antibody Unit (BAU)/mL Standard Deviation 1012.7	1849.9 Binding Antibody Unit (BAU)/mL Standard Deviation 1693.2	3432.9 Binding Antibody Unit (BAU)/mL Standard Deviation 5246.8	2227.5 Binding Antibody Unit (BAU)/mL Standard Deviation 2300.0	3358.0 Binding Antibody Unit (BAU)/mL Standard Deviation 4515.3	1980.6 Binding Antibody Unit (BAU)/mL Standard Deviation 1470.2	2361.7 Binding Antibody Unit (BAU)/mL Standard Deviation 2513.4
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 168 Days after 1st Vaccine	2208.7 Binding Antibody Unit (BAU)/mL Standard Deviation 3093.8	2156.7 Binding Antibody Unit (BAU)/mL Standard Deviation 4354.7	900.0 Binding Antibody Unit (BAU)/mL Standard Deviation 2018.7	1862.8 Binding Antibody Unit (BAU)/mL Standard Deviation 3723.4	2973.3 Binding Antibody Unit (BAU)/mL Standard Deviation 4045.5	1346.4 Binding Antibody Unit (BAU)/mL Standard Deviation 1762.0	4609.3 Binding Antibody Unit (BAU)/mL Standard Deviation 5678.3	940.1 Binding Antibody Unit (BAU)/mL Standard Deviation 1486.8	729.5 Binding Antibody Unit (BAU)/mL Standard Deviation 889.1
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 252 Days after 1st Vaccine	6319.0 Binding Antibody Unit (BAU)/mL Standard Deviation 6625.5	5682.5 Binding Antibody Unit (BAU)/mL Standard Deviation 6074.3	4138.0 Binding Antibody Unit (BAU)/mL Standard Deviation 5343.0	7004.3 Binding Antibody Unit (BAU)/mL Standard Deviation 7077.5	4784.2 Binding Antibody Unit (BAU)/mL Standard Deviation 4832.5	4974.1 Binding Antibody Unit (BAU)/mL Standard Deviation 6150.0	6830.1 Binding Antibody Unit (BAU)/mL Standard Deviation 5394.9	6806.3 Binding Antibody Unit (BAU)/mL Standard Deviation 7138.7	6855.6 Binding Antibody Unit (BAU)/mL Standard Deviation 7833.3
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 365 Days after 1st Vaccine	5724.1 Binding Antibody Unit (BAU)/mL Standard Deviation 4944.5	8865.1 Binding Antibody Unit (BAU)/mL Standard Deviation 7110.6	7888.9 Binding Antibody Unit (BAU)/mL Standard Deviation 7014.8	7596.9 Binding Antibody Unit (BAU)/mL Standard Deviation 7438.6	4954.4 Binding Antibody Unit (BAU)/mL Standard Deviation 5226.5	5263.3 Binding Antibody Unit (BAU)/mL Standard Deviation 6235.8	3819.3 Binding Antibody Unit (BAU)/mL Standard Deviation 3262.7	9836.6 Binding Antibody Unit (BAU)/mL Standard Deviation 7299.8	10863.1 Binding Antibody Unit (BAU)/mL Standard Deviation 7822.4

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 56 Days after 1st Vaccine	1.2 Fold Change	1.5 Fold Change	1.8 Fold Change	1.1 Fold Change	1.4 Fold Change	1.6 Fold Change	1.6 Fold Change	1.6 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) Baseline	0.4 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 6 Days after 1st Vaccine	—	—	—	—	—	0.5 Fold Change	—	—	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 14 Days after 1st Vaccine	1.6 Fold Change	1.7 Fold Change	1.8 Fold Change	3.5 Fold Change	2.5 Fold Change	1.0 Fold Change	2.4 Fold Change	2.1 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 28 Days after 1st Vaccine	3.1 Fold Change	4.1 Fold Change	3.7 Fold Change	2.8 Fold Change	3.7 Fold Change	2.6 Fold Change	2.3 Fold Change	2.9 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 42 Days after 1st Vaccine	1.1 Fold Change	1.5 Fold Change	1.6 Fold Change	1.1 Fold Change	1.4 Fold Change	1.2 Fold Change	1.3 Fold Change	1.4 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 168 Days after 1st Vaccine	1.7 Fold Change	1.7 Fold Change	1.8 Fold Change	0.4 Fold Change	1.1 Fold Change	0.4 Fold Change	1.3 Fold Change	1.5 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 252 Days after 1st Vaccine	1.1 Fold Change	1.4 Fold Change	0.6 Fold Change	1.2 Fold Change	1.2 Fold Change	0.5 Fold Change	1.0 Fold Change	1.2 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 365 Days after 1st Vaccine	0.7 Fold Change	0.7 Fold Change	0.9 Fold Change	1.6 Fold Change	1.8 Fold Change	1.4 Fold Change	0.5 Fold Change	0.5 Fold Change	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S protein (Spike) Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) Baseline	58.9 Percent Interval 15.4 to 118.9	3.0 Percent Interval -25.3 to 41.9	-18.7 Percent Interval -41.0 to 12.0	18.3 Percent Interval -13.5 to 61.9	29.4 Percent Interval -6.9 to 79.8	5.4 Percent Interval -24.5 to 47.1	-22.9 Percent Interval -43.0 to 4.2	-10.3 Percent Interval -33.8 to 21.5	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 6 Days after 1st Vaccine	—	—	—	—	—	88.0 Percent Interval -65.3 to 919.3	—	—	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 14 Days after 1st Vaccine	-25.1 Percent Interval -60.2 to 41.0	-48.5 Percent Interval -72.9 to -2.1	-44.5 Percent Interval -70.8 to 5.4	-29.9 Percent Interval -62.2 to 30.2	-47.8 Percent Interval -72.8 to -0.2	8.2 Percent Interval -43.5 to 107.0	-34.0 Percent Interval -63.8 to 20.3	-28.3 Percent Interval -60.6 to 30.4	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 28 Days after 1st Vaccine	-45.5 Percent Interval -70.6 to 1.0	-64.1 Percent Interval -80.6 to -33.4	-63.4 Percent Interval -80.3 to -32.1	-33.8 Percent Interval -63.8 to 21.0	-57.0 Percent Interval -77.2 to -19.1	-28.4 Percent Interval -62.0 to 34.9	-38.6 Percent Interval -65.6 to 9.8	-45.7 Percent Interval -69.7 to -2.6	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 42 Days after 1st Vaccine	-25.5 Percent Interval -52.2 to 16.3	-50.1 Percent Interval -67.9 to -22.6	-45.9 Percent Interval -65.1 to -16.0	-15.3 Percent Interval -44.9 to 30.2	-46.7 Percent Interval -66.7 to -14.7	-46.4 Percent Interval -66.8 to -13.5	-35.4 Percent Interval -57.3 to -2.3	-34.7 Percent Interval -57.1 to -0.6	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 56 Days after 1st Vaccine	6.2 Percent Interval -33.3 to 69.1	-34.8 Percent Interval -58.6 to 2.8	-36.6 Percent Interval -59.7 to -0.1	-6.9 Percent Interval -40.3 to 45.1	-23.6 Percent Interval -52.7 to 23.3	-18.9 Percent Interval -49.8 to 30.9	-29.1 Percent Interval -53.8 to 8.7	-20.9 Percent Interval -48.8 to 22.1	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 168 Days after 1st Vaccine	-29.1 Percent Interval -61.4 to 30.1	-54.2 Percent Interval -74.9 to -16.5	-29.5 Percent Interval -61.0 to 27.5	48.6 Percent Interval -18.4 to 170.8	-9.3 Percent Interval -51.5 to 69.4	98.9 Percent Interval 5.6 to 274.8	-40.6 Percent Interval -66.2 to 4.3	-48.0 Percent Interval -70.5 to -8.3	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 252 Days after 1st Vaccine	-13.4 Percent Interval -61.3 to 93.9	-47.4 Percent Interval -76.6 to 17.9	4.4 Percent Interval -52.4 to 129.3	-2.6 Percent Interval -57.6 to 123.5	-5.2 Percent Interval -60.8 to 129.3	49.1 Percent Interval -36.4 to 249.7	28.2 Percent Interval -41.2 to 179.4	-12.2 Percent Interval -59.0 to 87.9	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgG) 365 Days after 1st Vaccine	65.6 Percent Interval -10.0 to 204.6	44.0 Percent Interval -21.1 to 163.0	38.1 Percent Interval -22.6 to 146.4	-3.1 Percent Interval -46.9 to 76.9	-20.2 Percent Interval -58.3 to 53.0	-23.9 Percent Interval -59.4 to 42.4	78.7 Percent Interval 0.7 to 217.0	116.6 Percent Interval 23.7 to 279.3	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S1-RBD

Outcome measures

Outcome measures
Measure	Vaccine Only n=42 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=24 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) Baseline	6.6 Binding Antibody Unit (BAU)/mL Standard Deviation 4.0	14.0 Binding Antibody Unit (BAU)/mL Standard Deviation 21.4	6.8 Binding Antibody Unit (BAU)/mL Standard Deviation 2.8	5.6 Binding Antibody Unit (BAU)/mL Standard Deviation 3.0	9.0 Binding Antibody Unit (BAU)/mL Standard Deviation 6.0	111.4 Binding Antibody Unit (BAU)/mL Standard Deviation 512.7	9.2 Binding Antibody Unit (BAU)/mL Standard Deviation 8.7	5.4 Binding Antibody Unit (BAU)/mL Standard Deviation 2.4	7.5 Binding Antibody Unit (BAU)/mL Standard Deviation 10.3
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 6 Days after 1st Vaccine	7.2 Binding Antibody Unit (BAU)/mL Standard Deviation 2.8	—	—	—	—	—	940.8 Binding Antibody Unit (BAU)/mL Standard Deviation 4569.2	—	—
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 14 Days after 1st Vaccine	403.4 Binding Antibody Unit (BAU)/mL Standard Deviation 650.2	521.4 Binding Antibody Unit (BAU)/mL Standard Deviation 1411.9	185.9 Binding Antibody Unit (BAU)/mL Standard Deviation 262.0	153.1 Binding Antibody Unit (BAU)/mL Standard Deviation 218.2	2830.5 Binding Antibody Unit (BAU)/mL Standard Deviation 9711.1	493.7 Binding Antibody Unit (BAU)/mL Standard Deviation 1936.3	1340.3 Binding Antibody Unit (BAU)/mL Standard Deviation 5510.0	159.7 Binding Antibody Unit (BAU)/mL Standard Deviation 165.2	290.9 Binding Antibody Unit (BAU)/mL Standard Deviation 729.9
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 28 Days after 1st Vaccine	809.4 Binding Antibody Unit (BAU)/mL Standard Deviation 1100.8	448.4 Binding Antibody Unit (BAU)/mL Standard Deviation 841.7	206.0 Binding Antibody Unit (BAU)/mL Standard Deviation 177.2	182.3 Binding Antibody Unit (BAU)/mL Standard Deviation 214.1	2050.2 Binding Antibody Unit (BAU)/mL Standard Deviation 6594.9	418.5 Binding Antibody Unit (BAU)/mL Standard Deviation 1282.0	1417.6 Binding Antibody Unit (BAU)/mL Standard Deviation 5411.7	353.5 Binding Antibody Unit (BAU)/mL Standard Deviation 434.6	597.0 Binding Antibody Unit (BAU)/mL Standard Deviation 2153.3
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 42 Days after 1st Vaccine	7638.6 Binding Antibody Unit (BAU)/mL Standard Deviation 7214.2	7336.3 Binding Antibody Unit (BAU)/mL Standard Deviation 6920.7	4969.6 Binding Antibody Unit (BAU)/mL Standard Deviation 4706.1	4776.7 Binding Antibody Unit (BAU)/mL Standard Deviation 5241.9	10764.3 Binding Antibody Unit (BAU)/mL Standard Deviation 17718.4	3229.9 Binding Antibody Unit (BAU)/mL Standard Deviation 1467.4	5665.7 Binding Antibody Unit (BAU)/mL Standard Deviation 5297.2	4342.8 Binding Antibody Unit (BAU)/mL Standard Deviation 3047.2	4537.6 Binding Antibody Unit (BAU)/mL Standard Deviation 4153.6
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 56 Days after 1st Vaccine	5595.6 Binding Antibody Unit (BAU)/mL Standard Deviation 6439.6	6945.4 Binding Antibody Unit (BAU)/mL Standard Deviation 10762.4	3123.9 Binding Antibody Unit (BAU)/mL Standard Deviation 1915.7	3148.8 Binding Antibody Unit (BAU)/mL Standard Deviation 3404.7	7023.8 Binding Antibody Unit (BAU)/mL Standard Deviation 14395.7	4077.9 Binding Antibody Unit (BAU)/mL Standard Deviation 4581.2	4864.7 Binding Antibody Unit (BAU)/mL Standard Deviation 6282.4	3080.5 Binding Antibody Unit (BAU)/mL Standard Deviation 2507.4	3775.4 Binding Antibody Unit (BAU)/mL Standard Deviation 3840.3
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 168 Days after 1st Vaccine	4007.7 Binding Antibody Unit (BAU)/mL Standard Deviation 6218.6	4208.6 Binding Antibody Unit (BAU)/mL Standard Deviation 9593.8	1578.5 Binding Antibody Unit (BAU)/mL Standard Deviation 3810.3	3438.9 Binding Antibody Unit (BAU)/mL Standard Deviation 7459.7	5873.1 Binding Antibody Unit (BAU)/mL Standard Deviation 9336.1	2243.6 Binding Antibody Unit (BAU)/mL Standard Deviation 3035.3	10359.9 Binding Antibody Unit (BAU)/mL Standard Deviation 14463.6	1372.4 Binding Antibody Unit (BAU)/mL Standard Deviation 2310.7	1262.8 Binding Antibody Unit (BAU)/mL Standard Deviation 1957.9
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 252 Days after 1st Vaccine	13505.1 Binding Antibody Unit (BAU)/mL Standard Deviation 15811.0	13428.1 Binding Antibody Unit (BAU)/mL Standard Deviation 15027.8	9549.2 Binding Antibody Unit (BAU)/mL Standard Deviation 14673.8	1487.0 Binding Antibody Unit (BAU)/mL Standard Deviation 18618.2	9124.4 Binding Antibody Unit (BAU)/mL Standard Deviation 11583.7	11189.1 Binding Antibody Unit (BAU)/mL Standard Deviation 16641.6	12902.6 Binding Antibody Unit (BAU)/mL Standard Deviation 10578.8	14503.6 Binding Antibody Unit (BAU)/mL Standard Deviation 19241.8	17456.8 Binding Antibody Unit (BAU)/mL Standard Deviation 23681.5
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 365 Days after 1st Vaccine	11268.3 Binding Antibody Unit (BAU)/mL Standard Deviation 11087.5	21517.0 Binding Antibody Unit (BAU)/mL Standard Deviation 23659.3	16569.7 Binding Antibody Unit (BAU)/mL Standard Deviation 15884.0	16959.2 Binding Antibody Unit (BAU)/mL Standard Deviation 20989.3	10225.9 Binding Antibody Unit (BAU)/mL Standard Deviation 13257.7	11261.7 Binding Antibody Unit (BAU)/mL Standard Deviation 15375.7	6301.3 Binding Antibody Unit (BAU)/mL Standard Deviation 5284.8	19774.5 Binding Antibody Unit (BAU)/mL Standard Deviation 16462.8	23135.5 Binding Antibody Unit (BAU)/mL Standard Deviation 19481.4

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S1-RBD protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 252 Days after 1st Vaccine	0.9 Fold Change	1.9 Fold Change	0.9 Fold Change	1.5 Fold Change	1.8 Fold Change	0.7 Fold Change	1.1 Fold Change	1.5 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) Baseline	0.4 Fold Change	0.7 Fold Change	1.0 Fold Change	0.5 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 6 Days after 1st Vaccine	—	—	—	—	—	1.0 Fold Change	—	—	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 14 Days after 1st Vaccine	2.1 Fold Change	2.3 Fold Change	3.4 Fold Change	3.5 Fold Change	3.0 Fold Change	1.3 Fold Change	2.3 Fold Change	2.6 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 28 Days after 1st Vaccine	2.8 Fold Change	3.5 Fold Change	4.2 Fold Change	2.6 Fold Change	4.0 Fold Change	2.2 Fold Change	2.2 Fold Change	2.7 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 42 Days after 1st Vaccine	1.1 Fold Change	1.3 Fold Change	1.5 Fold Change	1.0 Fold Change	1.4 Fold Change	1.3 Fold Change	1.3 Fold Change	1.2 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 56 Days after 1st Vaccine	1.1 Fold Change	1.3 Fold Change	1.8 Fold Change	1.2 Fold Change	1.3 Fold Change	1.5 Fold Change	1.5 Fold Change	1.6 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 168 Days after 1st Vaccine	1.8 Fold Change	1.6 Fold Change	1.5 Fold Change	0.4 Fold Change	0.9 Fold Change	0.3 Fold Change	1.3 Fold Change	1.5 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 365 Days after 1st Vaccine	0.7 Fold Change	0.6 Fold Change	0.8 Fold Change	1.4 Fold Change	1.6 Fold Change	1.4 Fold Change	0.5 Fold Change	0.4 Fold Change	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S1-RBD protein Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 42 Days after 1st Vaccine	-11.8 Percent Interval -45.9 to 43.7	-41.2 Percent Interval -63.7 to -4.6	-40.7 Percent Interval -63.4 to -3.8	-0.0 Percent Interval -37.6 to 60.3	-44.0 Percent Interval -66.6 to -6.1	-46.4 Percent Interval -68.3 to -9.4	-30.3 Percent Interval -55.8 to 9.8	-27.5 Percent Interval -54.3 to 15.1	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 365 Days after 1st Vaccine	102.8 Percent Interval 4.5 to 293.4	63.5 Percent Interval -15.1 to 214.7	45.5 Percent Interval -22.5 to 173.1	2.7 Percent Interval -46.6 to 97.5	-14.9 Percent Interval -58.1 to 72.6	-27.8 Percent Interval -63.5 to 42.8	82.8 Percent Interval -2.0 to 241.1	145.7 Percent Interval 33.6 to 351.9	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) Baseline	58.3 Percent Interval 13.8 to 120.2	7.3 Percent Interval -22.9 to 49.4	-13.0 Percent Interval -37.5 to 21.1	27.5 Percent Interval -7.7 to 76.1	25.8 Percent Interval -10.4 to 76.5	18.2 Percent Interval -16.2 to 66.7	-14.3 Percent Interval -37.2 to 17.0	-9.0 Percent Interval -33.4 to 24.4	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 6 Days after 1st Vaccine	—	—	—	—	—	43.3 Percent Interval -72.8 to 654.8	—	—	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 14 Days after 1st Vaccine	-35.5 Percent Interval -67.0 to 26.1	-53.3 Percent Interval -76.3 to -7.7	-59.9 Percent Interval -79.7 to -20.9	-38.5 Percent Interval -68.1 to 18.4	-56.2 Percent Interval -78.0 to -12.9	-16.4 Percent Interval -58.0 to 66.5	-44.1 Percent Interval -70.4 to 5.6	-39.1 Percent Interval -67.7 to 14.8	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 28 Days after 1st Vaccine	-50.8 Percent Interval -74.3 to -6.0	-66.0 Percent Interval -82.2 to -34.8	-71.3 Percent Interval -85.0 to -45.0	-43.2 Percent Interval -69.8 to 7.1	-60.6 Percent Interval -79.7 to -23.4	-40.7 Percent Interval -69.5 to 15.2	-46.4 Percent Interval -70.9 to -1.5	-52.0 Percent Interval -74.0 to -11.5	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 56 Days after 1st Vaccine	14.8 Percent Interval -29.8 to 87.5	-29.3 Percent Interval -56.2 to 14.2	-34.5 Percent Interval -59.4 to 5.8	-0.3 Percent Interval -37.6 to 59.2	-10.8 Percent Interval -46.2 to 47.8	-19.1 Percent Interval -51.2 to 34.1	-28.3 Percent Interval -54.4 to 12.5	-14.2 Percent Interval -45.7 to 35.6	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 168 Days after 1st Vaccine	-26.0 Percent Interval -62.0 to 44.1	-50.5 Percent Interval -74.4 to -4.3	-20.4 Percent Interval -58.4 to 52.6	60.7 Percent Interval -16.8 to 210.5	-3.1 Percent Interval -51.2 to 92.5	135.3 Percent Interval 17.4 to 371.6	-45.2 Percent Interval -70.4 to 1.8	-45.2 Percent Interval -70.6 to 2.1	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgG) 252 Days after 1st Vaccine	-3.9 Percent Interval -61.0 to 136.6	-48.3 Percent Interval -79.1 to 27.6	10.5 Percent Interval -54.2 to 166.3	-6.6 Percent Interval -63.1 to 136.6	-1.4 Percent Interval -63.3 to 164.8	48.4 Percent Interval -42.8 to 285.2	19.1 Percent Interval -50.2 to 184.7	1.8 Percent Interval -56.5 to 138.4	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S1-RBD

Outcome measures

Outcome measures
Measure	Vaccine Only n=42 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=24 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 365 Days after 1st Vaccine	9.2 Binding Antibody Unit (BAU)/mL Standard Deviation 6.5	8.6 Binding Antibody Unit (BAU)/mL Standard Deviation 5.6	8.1 Binding Antibody Unit (BAU)/mL Standard Deviation 6.4	9.6 Binding Antibody Unit (BAU)/mL Standard Deviation 9.7	13.7 Binding Antibody Unit (BAU)/mL Standard Deviation 18.3	7.2 Binding Antibody Unit (BAU)/mL Standard Deviation 5.7	14.6 Binding Antibody Unit (BAU)/mL Standard Deviation 22.8	10.6 Binding Antibody Unit (BAU)/mL Standard Deviation 15.7	11.8 Binding Antibody Unit (BAU)/mL Standard Deviation 13.5
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) Baseline	7.0 Binding Antibody Unit (BAU)/mL Standard Deviation 7.3	7.1 Binding Antibody Unit (BAU)/mL Standard Deviation 5.2	7.5 Binding Antibody Unit (BAU)/mL Standard Deviation 7.7	6.4 Binding Antibody Unit (BAU)/mL Standard Deviation 4.1	6.5 Binding Antibody Unit (BAU)/mL Standard Deviation 6.8	6.9 Binding Antibody Unit (BAU)/mL Standard Deviation 4.2	7.0 Binding Antibody Unit (BAU)/mL Standard Deviation 4.9	6.1 Binding Antibody Unit (BAU)/mL Standard Deviation 3.2	5.7 Binding Antibody Unit (BAU)/mL Standard Deviation 2.6
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 6 Days after 1st Vaccine	8.9 Binding Antibody Unit (BAU)/mL Standard Deviation 6.8	—	—	—	—	—	13.1 Binding Antibody Unit (BAU)/mL Standard Deviation 20.9	—	—
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 14 Days after 1st Vaccine	53.8 Binding Antibody Unit (BAU)/mL Standard Deviation 70.8	29.2 Binding Antibody Unit (BAU)/mL Standard Deviation 38.7	25.5 Binding Antibody Unit (BAU)/mL Standard Deviation 26.2	35.1 Binding Antibody Unit (BAU)/mL Standard Deviation 64.5	852.6 Binding Antibody Unit (BAU)/mL Standard Deviation 4399.3	14.3 Binding Antibody Unit (BAU)/mL Standard Deviation 13.9	42.3 Binding Antibody Unit (BAU)/mL Standard Deviation 47.9	774.5 Binding Antibody Unit (BAU)/mL Standard Deviation 4180.7	34.4 Binding Antibody Unit (BAU)/mL Standard Deviation 81.2
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 28 Days after 1st Vaccine	34.5 Binding Antibody Unit (BAU)/mL Standard Deviation 32.4	17.3 Binding Antibody Unit (BAU)/mL Standard Deviation 22.3	14.8 Binding Antibody Unit (BAU)/mL Standard Deviation 16.0	17.5 Binding Antibody Unit (BAU)/mL Standard Deviation 25.1	848.9 Binding Antibody Unit (BAU)/mL Standard Deviation 4400.0	14.2 Binding Antibody Unit (BAU)/mL Standard Deviation 16.1	27.3 Binding Antibody Unit (BAU)/mL Standard Deviation 28.1	750.8 Binding Antibody Unit (BAU)/mL Standard Deviation 4114.9	17.9 Binding Antibody Unit (BAU)/mL Standard Deviation 39.7
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 42 Days after 1st Vaccine	55.5 Binding Antibody Unit (BAU)/mL Standard Deviation 57.2	38.5 Binding Antibody Unit (BAU)/mL Standard Deviation 55.9	20.3 Binding Antibody Unit (BAU)/mL Standard Deviation 16.8	21.7 Binding Antibody Unit (BAU)/mL Standard Deviation 18.3	869.2 Binding Antibody Unit (BAU)/mL Standard Deviation 4396.1	37.9 Binding Antibody Unit (BAU)/mL Standard Deviation 33.7	40.5 Binding Antibody Unit (BAU)/mL Standard Deviation 38.4	762.2 Binding Antibody Unit (BAU)/mL Standard Deviation 4113.0	29.0 Binding Antibody Unit (BAU)/mL Standard Deviation 35.5
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 56 Days after 1st Vaccine	34.1 Binding Antibody Unit (BAU)/mL Standard Deviation 34.9	20.6 Binding Antibody Unit (BAU)/mL Standard Deviation 29.4	11.8 Binding Antibody Unit (BAU)/mL Standard Deviation 9.7	12.2 Binding Antibody Unit (BAU)/mL Standard Deviation 9.3	37.0 Binding Antibody Unit (BAU)/mL Standard Deviation 79.2	19.8 Binding Antibody Unit (BAU)/mL Standard Deviation 16.7	27.1 Binding Antibody Unit (BAU)/mL Standard Deviation 23.3	30.9 Binding Antibody Unit (BAU)/mL Standard Deviation 63.0	17.6 Binding Antibody Unit (BAU)/mL Standard Deviation 19.9
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 168 Days after 1st Vaccine	11.7 Binding Antibody Unit (BAU)/mL Standard Deviation 9.5	8.9 Binding Antibody Unit (BAU)/mL Standard Deviation 6.1	8.7 Binding Antibody Unit (BAU)/mL Standard Deviation 10.6	10.8 Binding Antibody Unit (BAU)/mL Standard Deviation 14.4	15.8 Binding Antibody Unit (BAU)/mL Standard Deviation 22.1	9.4 Binding Antibody Unit (BAU)/mL Standard Deviation 10.9	12.1 Binding Antibody Unit (BAU)/mL Standard Deviation 9.2	9.1 Binding Antibody Unit (BAU)/mL Standard Deviation 11.4	6.5 Binding Antibody Unit (BAU)/mL Standard Deviation 4.4
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 252 Days after 1st Vaccine	13.6 Binding Antibody Unit (BAU)/mL Standard Deviation 13.3	10.2 Binding Antibody Unit (BAU)/mL Standard Deviation 6.9	11.1 Binding Antibody Unit (BAU)/mL Standard Deviation 12.7	10.5 Binding Antibody Unit (BAU)/mL Standard Deviation 9.1	17.9 Binding Antibody Unit (BAU)/mL Standard Deviation 36.1	10.2 Binding Antibody Unit (BAU)/mL Standard Deviation 12.6	12.8 Binding Antibody Unit (BAU)/mL Standard Deviation 18.5	875.0 Binding Antibody Unit (BAU)/mL Standard Deviation 4481.7	16.9 Binding Antibody Unit (BAU)/mL Standard Deviation 22.8

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints.

Anti-S1-RBD protein Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 365 Days after 1st Vaccine	-4.0 Percent Interval -34.7 to 41.1	-12.4 Percent Interval -40.2 to 28.1	-6.6 Percent Interval -35.2 to 34.7	8.3 Percent Interval -26.0 to 58.4	-19.1 Percent Interval -46.4 to 22.1	13.5 Percent Interval -23.7 to 68.8	-8.7 Percent Interval -36.5 to 31.2	8.1 Percent Interval -24.1 to 54.1	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) Baseline	5.9 Percent Interval -15.9 to 33.5	3.5 Percent Interval -17.9 to 30.5	-1.5 Percent Interval -21.8 to 24.2	-4.7 Percent Interval -24.1 to 19.5	6.0 Percent Interval -16.4 to 34.5	3.6 Percent Interval -18.6 to 31.8	-1.7 Percent Interval -20.9 to 22.3	-4.9 Percent Interval -23.6 to 18.4	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 14 Days after 1st Vaccine	-43.7 Percent Interval -69.0 to 2.3	-50.9 Percent Interval -73.2 to -10.0	-54.7 Percent Interval -75.3 to -16.9	-36.7 Percent Interval -64.7 to 13.7	-62.8 Percent Interval -79.9 to -31.3	-10.9 Percent Interval -51.7 to 64.7	-34.9 Percent Interval -63.1 to 14.8	-41.0 Percent Interval -66.5 to 3.8	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 28 Days after 1st Vaccine	-46.6 Percent Interval -70.0 to -5.1	-53.6 Percent Interval -73.9 to -17.3	-53.3 Percent Interval -73.8 to -17.0	-26.5 Percent Interval -58.2 to 29.0	-52.0 Percent Interval to -13.4	-15.5 Percent Interval -53.2 to 52.5	-27.7 Percent Interval -57.9 to 24.3	-51.3 Percent Interval -71.7 to -16.0	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 42 Days after 1st Vaccine	-22.7 Percent Interval -56.1 to 36.4	-55.9 Percent Interval -74.8 to -22.7	-51.5 Percent Interval -72.3 to -15.1	8.0 Percent Interval -37.6 to 86.8	-18.2 Percent Interval -55.1 to 49.2	-20.2 Percent Interval -56.6 to 46.9	-36.3 Percent Interval -62.4 to 8.0	-43.0 Percent Interval -66.7 to -2.5	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 56 Days after 1st Vaccine	-33.6 Percent Interval -58.8 to 7.2	-58.2 Percent Interval -73.8 to -33.2	-56.6 Percent Interval -72.8 to -30.8	-16.8 Percent Interval -47.3 to 31.3	-32.9 Percent Interval -59.0 to 9.8	-14.0 Percent Interval -47.5 to 40.6	-37.7 Percent Interval -59.8 to -3.2	-42.3 Percent Interval -63.1 to -9.8	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 168 Days after 1st Vaccine	-18.5 Percent Interval -42.5 to 15.5	-30.5 Percent Interval -50.8 to -1.8	-17.8 Percent Interval -41.5 to 15.6	6.8 Percent Interval -24.3 to 50.8	-23.8 Percent Interval -46.8 to 9.1	3.2 Percent Interval -28.3 to 48.5	-27.3 Percent Interval -47.4 to 0.5	-35.4 Percent Interval -53.4 to -10.5	—
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 252 Days after 1st Vaccine	-15.2 Percent Interval -48.4 to 39.1	-20.0 Percent Interval -51.3 to 31.6	-19.3 Percent Interval -50.3 to 30.9	-17.2 Percent Interval -50.3 to 38.1	-22.3 Percent Interval -54.9 to 33.8	-13.0 Percent Interval -48.5 to 46.9	20.6 Percent Interval -25.3 to 94.8	6.4 Percent Interval -33.4 to 69.9	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints.

Anti-S1-RBD protein Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) Baseline	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 14 Days after 1st Vaccine	1.9 Fold Change	1.8 Fold Change	2.6 Fold Change	2.4 Fold Change	3.3 Fold Change	1.0 Fold Change	2.1 Fold Change	2.3 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 28 Days after 1st Vaccine	2.3 Fold Change	3.1 Fold Change	5.0 Fold Change	2.1 Fold Change	5.0 Fold Change	1.4 Fold Change	2.3 Fold Change	5.0 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 42 Days after 1st Vaccine	2.0 Fold Change	2.4 Fold Change	2.8 Fold Change	1.6 Fold Change	1.9 Fold Change	1.5 Fold Change	3.1 Fold Change	2.3 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 56 Days after 1st Vaccine	1.5 Fold Change	2.8 Fold Change	2.8 Fold Change	1.1 Fold Change	1.4 Fold Change	0.9 Fold Change	1.7 Fold Change	1.6 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 168 Days after 1st Vaccine	2.1 Fold Change	2.1 Fold Change	2.1 Fold Change	2.1 Fold Change	2.1 Fold Change	0.9 Fold Change	2.1 Fold Change	2.1 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 252 Days after 1st Vaccine	2.1 Fold Change	2.1 Fold Change	2.1 Fold Change	2.1 Fold Change	2.1 Fold Change	2.1 Fold Change	2.1 Fold Change	1.0 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgM) 365 Days after 1st Vaccine	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S protein (Spike protein)

Outcome measures

Outcome measures
Measure	Vaccine Only n=42 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=24 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) Baseline	5.1 Binding Antibody Unit (BAU)/mL Standard Deviation 5.6	5.7 Binding Antibody Unit (BAU)/mL Standard Deviation 6.6	7.1 Binding Antibody Unit (BAU)/mL Standard Deviation 9.6	5.7 Binding Antibody Unit (BAU)/mL Standard Deviation 6.3	3.9 Binding Antibody Unit (BAU)/mL Standard Deviation 2.9	4.8 Binding Antibody Unit (BAU)/mL Standard Deviation 3.5	4.3 Binding Antibody Unit (BAU)/mL Standard Deviation 2.9	3.7 Binding Antibody Unit (BAU)/mL Standard Deviation 2.0	4.3 Binding Antibody Unit (BAU)/mL Standard Deviation 3.7
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 6 Days after 1st Vaccine	5.0 Binding Antibody Unit (BAU)/mL Standard Deviation 2.6	—	—	—	—	—	10.0 Binding Antibody Unit (BAU)/mL Standard Deviation 21.3	—	—
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 14 Days after 1st Vaccine	82.1 Binding Antibody Unit (BAU)/mL Standard Deviation 84.1	50.1 Binding Antibody Unit (BAU)/mL Standard Deviation 61.0	32.2 Binding Antibody Unit (BAU)/mL Standard Deviation 33.4	53.8 Binding Antibody Unit (BAU)/mL Standard Deviation 99.1	579.5 Binding Antibody Unit (BAU)/mL Standard Deviation 2919.4	21.4 Binding Antibody Unit (BAU)/mL Standard Deviation 21.8	57.9 Binding Antibody Unit (BAU)/mL Standard Deviation 56.6	535.1 Binding Antibody Unit (BAU)/mL Standard Deviation 2773.1	53.8 Binding Antibody Unit (BAU)/mL Standard Deviation 133.3
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 28 Days after 1st Vaccine	52.6 Binding Antibody Unit (BAU)/mL Standard Deviation 48.3	24.3 Binding Antibody Unit (BAU)/mL Standard Deviation 37.2	18.7 Binding Antibody Unit (BAU)/mL Standard Deviation 28.8	23.0 Binding Antibody Unit (BAU)/mL Standard Deviation 37.6	56.0 Binding Antibody Unit (BAU)/mL Standard Deviation 187.7	41.4 Binding Antibody Unit (BAU)/mL Standard Deviation 136.9	34.3 Binding Antibody Unit (BAU)/mL Standard Deviation 34.7	55.1 Binding Antibody Unit (BAU)/mL Standard Deviation 151.0	23.4 Binding Antibody Unit (BAU)/mL Standard Deviation 52.6
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 42 Days after 1st Vaccine	86.3 Binding Antibody Unit (BAU)/mL Standard Deviation 90.0	57.2 Binding Antibody Unit (BAU)/mL Standard Deviation 90.2	31.1 Binding Antibody Unit (BAU)/mL Standard Deviation 29.5	30.4 Binding Antibody Unit (BAU)/mL Standard Deviation 26.3	604.2 Binding Antibody Unit (BAU)/mL Standard Deviation 2914.7	66.2 Binding Antibody Unit (BAU)/mL Standard Deviation 85.5	61.4 Binding Antibody Unit (BAU)/mL Standard Deviation 57.3	65.5 Binding Antibody Unit (BAU)/mL Standard Deviation 111.5	42.8 Binding Antibody Unit (BAU)/mL Standard Deviation 47.5
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 56 Days after 1st Vaccine	50.3 Binding Antibody Unit (BAU)/mL Standard Deviation 58.4	28.1 Binding Antibody Unit (BAU)/mL Standard Deviation 44.0	17.8 Binding Antibody Unit (BAU)/mL Standard Deviation 20.9	14.2 Binding Antibody Unit (BAU)/mL Standard Deviation 10.6	47.7 Binding Antibody Unit (BAU)/mL Standard Deviation 96.6	32.3 Binding Antibody Unit (BAU)/mL Standard Deviation 39.8	42.2 Binding Antibody Unit (BAU)/mL Standard Deviation 43.1	40.3 Binding Antibody Unit (BAU)/mL Standard Deviation 74.5	25.9 Binding Antibody Unit (BAU)/mL Standard Deviation 29.1
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 168 Days after 1st Vaccine	10.4 Binding Antibody Unit (BAU)/mL Standard Deviation 9.6	7.0 Binding Antibody Unit (BAU)/mL Standard Deviation 6.4	8.8 Binding Antibody Unit (BAU)/mL Standard Deviation 12.4	9.7 Binding Antibody Unit (BAU)/mL Standard Deviation 14.0	16.6 Binding Antibody Unit (BAU)/mL Standard Deviation 21.9	11.5 Binding Antibody Unit (BAU)/mL Standard Deviation 13.4	12.1 Binding Antibody Unit (BAU)/mL Standard Deviation 8.5	7.0 Binding Antibody Unit (BAU)/mL Standard Deviation 10.6	5.9 Binding Antibody Unit (BAU)/mL Standard Deviation 4.8
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 252 Days after 1st Vaccine	13.1 Binding Antibody Unit (BAU)/mL Standard Deviation 13.9	9.6 Binding Antibody Unit (BAU)/mL Standard Deviation 6.9	10.2 Binding Antibody Unit (BAU)/mL Standard Deviation 11.0	9.3 Binding Antibody Unit (BAU)/mL Standard Deviation 6.8	19.9 Binding Antibody Unit (BAU)/mL Standard Deviation 45.7	11.7 Binding Antibody Unit (BAU)/mL Standard Deviation 13.4	14.1 Binding Antibody Unit (BAU)/mL Standard Deviation 18.5	38.4 Binding Antibody Unit (BAU)/mL Standard Deviation 147.4	15.7 Binding Antibody Unit (BAU)/mL Standard Deviation 19.1
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 365 Days after 1st Vaccine	8.8 Binding Antibody Unit (BAU)/mL Standard Deviation 7.6	8.9 Binding Antibody Unit (BAU)/mL Standard Deviation 6.4	9.5 Binding Antibody Unit (BAU)/mL Standard Deviation 9.9	8.3 Binding Antibody Unit (BAU)/mL Standard Deviation 6.9	13.0 Binding Antibody Unit (BAU)/mL Standard Deviation 20.4	8.0 Binding Antibody Unit (BAU)/mL Standard Deviation 6.6	13.1 Binding Antibody Unit (BAU)/mL Standard Deviation 18.6	9.3 Binding Antibody Unit (BAU)/mL Standard Deviation 10.0	12.5 Binding Antibody Unit (BAU)/mL Standard Deviation 13.1

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints.

Anti-S protein (Spike protein) Relative difference is calculated as: \[(LS Geometric Mean Active Arm - LS Geometric Mean Vaccine Alone Arm) / LS Geometric Mean Vaccine Alone Arm\] x 100%

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 365 Days after 1st Vaccine	4.0 Percent Interval -33.6 to 62.7	-1.3 Percent Interval -36.6 to 53.7	-5.7 Percent Interval -38.4 to 44.3	1.2 Percent Interval -35.0 to 57.5	-9.5 Percent Interval -43.9 to 46.0	5.6 Percent Interval -33.4 to 67.5	-3.0 Percent Interval -36.4 to 47.8	27.1 Percent Interval -15.8 to 91.9	—
Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) Baseline	8.9 Percent Interval -16.7 to 42.4	14.7 Percent Interval -12.4 to 50.1	6.3 Percent Interval -18.7 to 39.1	-12.1 Percent Interval -32.4 to 14.3	3.9 Percent Interval -21.1 to 36.9	-7.3 Percent Interval -29.9 to 22.6	-13.3 Percent Interval -32.7 to 11.6	-5.8 Percent Interval -26.9 to 21.5	—
Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 14 Days after 1st Vaccine	-42.1 Percent Interval -69.6 to 10.2	-58.9 Percent Interval -78.6 to -21.0	-60.1 Percent Interval -79.2 to -23.3	-54.7 Percent Interval -75.9 to -15.0	-66.8 Percent Interval -82.8 to -35.6	-21.8 Percent Interval -59.6 to 51.5	-40.2 Percent Interval -67.5 to 10.3	-44.7 Percent Interval -69.9 to 1.8	—
Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 28 Days after 1st Vaccine	-56.7 Percent Interval -76.4 to -20.4	-69.2 Percent Interval -83.3 to -43.4	-64.6 Percent Interval -80.7 to -35.0	-50.2 Percent Interval -72.5 to -9.8	-61.6 Percent Interval -79.4 to -28.4	-31.7 Percent Interval -63.4 to 27.4	-52.7 Percent Interval -73.3 to -16.3	-58.7 Percent Interval -76.8 to -26.7	—
Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 42 Days after 1st Vaccine	-32.5 Percent Interval -60.5 to 15.2	-63.0 Percent Interval -78.2 to -37.1	-56.9 Percent Interval -74.6 to -26.8	-7.5 Percent Interval -44.8 to 55.2	-19.2 Percent Interval -54.1 to 42.4	-21.1 Percent Interval -55.6 to 40.1	-46.7 Percent Interval -67.6 to -12.3	-43.7 Percent Interval -66.1 to -6.7	—
Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 56 Days after 1st Vaccine	-37.3 Percent Interval -63.3 to 6.9	-61.7 Percent Interval -77.3 to -35.5	-62.8 Percent Interval -77.9 to -37.3	-20.3 Percent Interval -52.1 to 32.7	-34.4 Percent Interval -62.1 to 13.7	-14.4 Percent Interval -50.6 to 48.2	-45.1 Percent Interval -66.4 to -10.3	-39.3 Percent Interval -63.1 to -0.1	—
Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 168 Days after 1st Vaccine	-29.0 Percent Interval -53.6 to 8.8	-33.0 Percent Interval -56.1 to 2.1	-19.5 Percent Interval -46.9 to 22.0	9.4 Percent Interval -28.2 to 66.7	-14.8 Percent Interval -45.0 to 32.2	17.4 Percent Interval -24.8 to 83.2	-37.2 Percent Interval -57.7 to -6.7	-35.9 Percent Interval -57.0 to -4.6	—
Relative Difference Expressed as a Percent in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 252 Days after 1st Vaccine	-19.7 Percent Interval -51.3 to 32.5	-31.0 Percent Interval -58.2 to 14.0	-21.1 Percent Interval -51.6 to 28.7	-22.1 Percent Interval -53.5 to 30.5	-17.5 Percent Interval -52.4 to 42.9	-3.1 Percent Interval -43.0 to 64.6	-4.5 Percent Interval -41.2 to 55.0	-2.6 Percent Interval -39.3 to 56.3	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Anti-S protein (Spike protein) Fold Change based on medians = (median value in vaccine only arm / median value in the active arm)

Outcome measures

Outcome measures
Measure	Vaccine Only n=26 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=24 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) Baseline	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	1.0 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 6 Days after 1st Vaccine	—	—	—	—	—	1.0 Fold Change	—	—	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 14 Days after 1st Vaccine	2.1 Fold Change	2.4 Fold Change	2.8 Fold Change	3.2 Fold Change	2.9 Fold Change	1.1 Fold Change	3.0 Fold Change	2.0 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 28 Days after 1st Vaccine	3.6 Fold Change	5.2 Fold Change	4.5 Fold Change	3.3 Fold Change	4.9 Fold Change	1.9 Fold Change	3.7 Fold Change	3.7 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 42 Days after 1st Vaccine	2.2 Fold Change	2.4 Fold Change	2.6 Fold Change	1.4 Fold Change	1.9 Fold Change	1.3 Fold Change	2.9 Fold Change	2.0 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 56 Days after 1st Vaccine	1.7 Fold Change	2.2 Fold Change	2.0 Fold Change	1.1 Fold Change	1.4 Fold Change	1.2 Fold Change	1.8 Fold Change	1.3 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 168 Days after 1st Vaccine	2.7 Fold Change	2.7 Fold Change	1.8 Fold Change	1.3 Fold Change	2.7 Fold Change	0.9 Fold Change	2.7 Fold Change	2.7 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 252 Days after 1st Vaccine	1.0 Fold Change	3.2 Fold Change	1.4 Fold Change	3.2 Fold Change	1.1 Fold Change	1.0 Fold Change	1.1 Fold Change	1.1 Fold Change	—
Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S-IgM) 365 Days after 1st Vaccine	0.9 Fold Change	1.0 Fold Change	0.9 Fold Change	2.2 Fold Change	2.2 Fold Change	2.2 Fold Change	1.1 Fold Change	0.9 Fold Change	—

SECONDARY outcome

Timeframe: Up to 365 Days from 1st dose of vaccination

Population: Per protocol set (PPS) includes all randomized participants who have received both doses of vaccine and who do not meet the exclusion criteria. The PPS is the primary analysis set for assessing vaccine response related endpoints. As was pre-specified in the study protocol, only participants in the "Vaccine Only" and " REGN10933+REGN10987 + Vaccine 1200 mg Day 7" Arm/Group were assessed for measure 6 days after the first vaccine.

Outcome measures

Outcome measures
Measure	Vaccine Only n=42 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=24 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=24 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=32 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to SARS-CoV-2 S Protein Assessed Over Time After the First Dose of Moderna mRNA-1273 Vaccine 168 Days	2889.5 Titer Standard Deviation 3890.9	1756.4 Titer Standard Deviation 2759.0	649.4 Titer Standard Deviation 791.1	1670.2 Titer Standard Deviation 2774.3	3316.2 Titer Standard Deviation 4137.5	1007.5 Titer Standard Deviation 871.8	2968.4 Titer Standard Deviation 3399.8	1261.4 Titer Standard Deviation 2139.7	974.6 Titer Standard Deviation 1124.6
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to SARS-CoV-2 S Protein Assessed Over Time After the First Dose of Moderna mRNA-1273 Vaccine Baseline	40.0 Titer Standard Deviation 0.0	40.0 Titer Standard Deviation 0.0	40.0 Titer Standard Deviation 0.0	40.0 Titer Standard Deviation 0.0	40.0 Titer Standard Deviation 0.0	40.0 Titer Standard Deviation 0.0	40.0 Titer Standard Deviation 0.0	40.0 Titer Standard Deviation 0.0	40.0 Titer Standard Deviation 0.0
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to SARS-CoV-2 S Protein Assessed Over Time After the First Dose of Moderna mRNA-1273 Vaccine 6 Days	40.0 Titer Standard Deviation 0.0	—	—	—	—	—	827.8 Titer Standard Deviation 3859.4	—	—
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to SARS-CoV-2 S Protein Assessed Over Time After the First Dose of Moderna mRNA-1273 Vaccine 14 Days	928.4 Titer Standard Deviation 4600.0	518.7 Titer Standard Deviation 1446.0	81.0 Titer Standard Deviation 59.9	84.2 Titer Standard Deviation 78.1	2686.8 Titer Standard Deviation 9365.3	780.4 Titer Standard Deviation 2955.9	1847.5 Titer Standard Deviation 6787.1	93.3 Titer Standard Deviation 78.8	1325.2 Titer Standard Deviation 6386.1
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to SARS-CoV-2 S Protein Assessed Over Time After the First Dose of Moderna mRNA-1273 Vaccine 28 Days	640.5 Titer Standard Deviation 2173.9	499.8 Titer Standard Deviation 1420.1	136.2 Titer Standard Deviation 169.8	177.7 Titer Standard Deviation 581.6	3887.0 Titer Standard Deviation 16628.4	631.3 Titer Standard Deviation 1955.2	785.6 Titer Standard Deviation 2134.7	113.7 Titer Standard Deviation 102.0	1108.3 Titer Standard Deviation 5103.2
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to SARS-CoV-2 S Protein Assessed Over Time After the First Dose of Moderna mRNA-1273 Vaccine 42 Days	4391.0 Titer Standard Deviation 4567.2	2623.7 Titer Standard Deviation 2216.8	1322.6 Titer Standard Deviation 1198.8	1284.8 Titer Standard Deviation 1434.1	6926.8 Titer Standard Deviation 14487.0	3744.3 Titer Standard Deviation 4066.7	4351.9 Titer Standard Deviation 4553.9	1418.2 Titer Standard Deviation 1414.8	2167.2 Titer Standard Deviation 5160.7
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to SARS-CoV-2 S Protein Assessed Over Time After the First Dose of Moderna mRNA-1273 Vaccine 56 Days	2594.9 Titer Standard Deviation 1981.5	1818.6 Titer Standard Deviation 2365.8	780.8 Titer Standard Deviation 771.1	716.1 Titer Standard Deviation 664.9	4922.8 Titer Standard Deviation 11157.3	2422.2 Titer Standard Deviation 2882.7	2576.8 Titer Standard Deviation 2736.1	980.8 Titer Standard Deviation 1015.1	1549.5 Titer Standard Deviation 4334.1
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to SARS-CoV-2 S Protein Assessed Over Time After the First Dose of Moderna mRNA-1273 Vaccine 252 Days	10110.8 Titer Standard Deviation 11107.8	3815.0 Titer Standard Deviation 4058.1	2712.6 Titer Standard Deviation 2898.7	4891.0 Titer Standard Deviation 5258.5	4844.8 Titer Standard Deviation 6960.8	6491.6 Titer Standard Deviation 12406.5	7311.4 Titer Standard Deviation 8802.4	7034.7 Titer Standard Deviation 9548.7	5041.1 Titer Standard Deviation 6443.0
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to SARS-CoV-2 S Protein Assessed Over Time After the First Dose of Moderna mRNA-1273 Vaccine 365 Days	7250.9 Titer Standard Deviation 6902.0	7184.3 Titer Standard Deviation 6172.6	3934.6 Titer Standard Deviation 3800.0	4408.0 Titer Standard Deviation 3941.0	7070.1 Titer Standard Deviation 9060.8	13175.9 Titer Standard Deviation 26414.2	4949.7 Titer Standard Deviation 4445.6	6287.3 Titer Standard Deviation 6023.3	7174.4 Titer Standard Deviation 7753.8

SECONDARY outcome

Timeframe: Up to 401 Days

Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated).

Outcome measures

Outcome measures
Measure	Vaccine Only n=48 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=29 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=33 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=31 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study	22 Participants	13 Participants	16 Participants	17 Participants	15 Participants	16 Participants	13 Participants	16 Participants	23 Participants

SECONDARY outcome

Timeframe: Up to 401 Days

Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated).

Outcome measures

Outcome measures
Measure	Vaccine Only n=48 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=29 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=33 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=31 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) Throughout the Study	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Through Day 4 post-infusion

Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated).

Outcome measures

Outcome measures
Measure	Vaccine Only n=48 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=29 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=33 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=31 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Number of Participants With Infusion-related Reactions (Grade ≥2) to REGN10933+REGN10987	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through Day 4 post-infusion

Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated).

Outcome measures

Outcome measures
Measure	Vaccine Only n=48 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=29 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=33 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=31 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Number of Participants With Injection Site Reactions (Grade ≥3) to REGN10933+REGN10987	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through Day 4 post-infusion

Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated).

Outcome measures

Outcome measures
Measure	Vaccine Only n=48 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=29 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=33 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=31 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Number of Participants With Injection Site Reactions (Grade ≥3) to Moderna mRNA-1273 Vaccine	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through Day 29 post-infusion or post-injection

Population: The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug; it is based on the treatment received (as treated). Groups assessment based on time and route of administration

Grade 2 - characterized by an adverse local or general response from exposure and oral intervention indicated Grade 3 - hospitalization indicated and intravenous response required Grade 4 - Life Threatening consequence and urgent intervention indicated Grade 5 - Death

Outcome measures

Outcome measures
Measure	Vaccine Only n=48 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=29 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=33 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=31 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Number of Participants With Hypersensitivity Reactions (Grade ≥2) to REGN10933+REGN10987 or Each Dose of Moderna mRNA-1273 Vaccine	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 182 Days

Population: The pharmacokinetics (PK) analysis sets (PKAS) are defined for each study drug separately and includes all subjects who received any study drug and who had at least 1 non-missing result following the first dose of the respective study drug.

Outcome measures

Outcome measures
Measure	Vaccine Only n=28 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=29 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=33 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=31 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Concentrations of REGN10933 in Serum Over Time 0 Days (Pre-dose)	0.0219 mg/L Standard Deviation 0.114	0 mg/L Standard Deviation 0	0 mg/L Standard Deviation 0	0 mg/L Standard Deviation 0	0 mg/L Standard Deviation 0	5.12 mg/L Standard Deviation 26.1	0 mg/L Standard Deviation 0	0 mg/L Standard Deviation 0	—
Concentrations of REGN10933 in Serum Over Time 0 Days (End of Infusion)	145 mg/L Standard Deviation 40.8	40.5 mg/L Standard Deviation 16.2	26.8 mg/L Standard Deviation 16.9	7.84 mg/L Standard Deviation 4.28	1.84 mg/L Standard Deviation 0.593	140 mg/L Standard Deviation 54.4	0.527 mg/L Standard Deviation 0.966	0.0765 mg/L Standard Deviation 0.160	—
Concentrations of REGN10933 in Serum Over Time 8 Days	—	—	—	—	—	63.7 mg/L Standard Deviation 11.7	—	—	—
Concentrations of REGN10933 in Serum Over Time 14 Days	46.8 mg/L Standard Deviation 11.3	12.7 mg/L Standard Deviation 3.79	8.30 mg/L Standard Deviation 3.94	2.62 mg/L Standard Deviation 1.44	0.536 mg/L Standard Deviation 0.229	—	39.4 mg/L Standard Deviation 11.5	20.4 mg/L Standard Deviation 7.48	—
Concentrations of REGN10933 in Serum Over Time 22 Days	—	—	—	—	—	39.1 mg/L Standard Deviation 10.9	—	—	—
Concentrations of REGN10933 in Serum Over Time 28 Days	29.5 mg/L Standard Deviation 9.89	8.24 mg/L Standard Deviation 3.02	5.12 mg/L Standard Deviation 2.28	1.76 mg/L Standard Deviation 1.13	0.354 mg/L Standard Deviation 0.150	—	26.0 mg/L Standard Deviation 8.04	14.7 mg/L Standard Deviation 6.25	—
Concentrations of REGN10933 in Serum Over Time 36 Days	—	—	—	—	—	27.7 mg/L Standard Deviation 7.80	—	—	—
Concentrations of REGN10933 in Serum Over Time 42 Days	18.7 mg/L Standard Deviation 7.98	5.38 mg/L Standard Deviation 2.40	3.35 mg/L Standard Deviation 1.71	1.19 mg/L Standard Deviation 0.861	0.237 mg/L Standard Deviation 0.114	—	17.5 mg/L Standard Deviation 6.30	9.77 mg/L Standard Deviation 5.01	—
Concentrations of REGN10933 in Serum Over Time 50 Days	—	—	—	—	—	19.3 mg/L Standard Deviation 5.45	—	—	—
Concentrations of REGN10933 in Serum Over Time 56 Days	13.4 mg/L Standard Deviation 5.87	3.51 mg/L Standard Deviation 1.78	2.10 mg/L Standard Deviation 1.14	0.754 mg/L Standard Deviation 0.569	0.131 mg/L Standard Deviation 0.142	—	11.6 mg/L Standard Deviation 5.04	6.70 mg/L Standard Deviation 3.77	—
Concentrations of REGN10933 in Serum Over Time 70 Days	9.98 mg/L Standard Deviation 6.06	2.34 mg/L Standard Deviation 1.33	1.42 mg/L Standard Deviation 0.804	0.522 mg/L Standard Deviation 0.456	0.0105 mg/L Standard Deviation 0.0408	—	—	—	—
Concentrations of REGN10933 in Serum Over Time 162 Days	—	—	—	—	—	1.38 mg/L Standard Deviation 1.00	—	—	—
Concentrations of REGN10933 in Serum Over Time 168 Days	—	—	—	—	—	—	0.891 mg/L Standard Deviation 0.712	0.615 mg/L Standard Deviation 0.797	—
Concentrations of REGN10933 in Serum Over Time 182 Days	0.898 mg/L Standard Deviation 1.06	0.180 mg/L Standard Deviation 0.212	0.137 mg/L Standard Deviation 0.356	0.00693 mg/L Standard Deviation 0.0360	0 mg/L Standard Deviation 0	—	—	—	—

SECONDARY outcome

Timeframe: Up to 182 Days

Population: The pharmacokinetics (PK) analysis sets (PKAS) are defined for each study drug separately and includes all subjects who received any study drug and who had at least 1 non-missing result following the first dose of the respective study drug.

Outcome measures

Outcome measures
Measure	Vaccine Only n=28 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=29 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=28 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=33 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=31 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=26 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Concentrations of REGN10987 in Serum Over Time 70 Days	6.51 mg/L Standard Deviation 4.53	1.57 mg/L Standard Deviation 1.04	0.993 mg/L Standard Deviation 0.630	0.306 mg/L Standard Deviation 0.344	0.0115 mg/L Standard Deviation 0.0444	—	—	—	—
Concentrations of REGN10987 in Serum Over Time 28 Days	23.8 mg/L Standard Deviation 9.92	6.87 mg/L Standard Deviation 2.84	4.19 mg/L Standard Deviation 1.95	1.46 mg/L Standard Deviation 0.968	0.263 mg/L Standard Deviation 0.189	—	21.0 mg/L Standard Deviation 6.95	12.1 mg/L Standard Deviation 5.92	—
Concentrations of REGN10987 in Serum Over Time 36 Days	—	—	—	—	—	22.2 mg/L Standard Deviation 6.56	—	—	—
Concentrations of REGN10987 in Serum Over Time 42 Days	13.7 mg/L Standard Deviation 6.86	4.00 mg/L Standard Deviation 2.02	2.54 mg/L Standard Deviation 1.35	0.868 mg/L Standard Deviation 0.641	0.138 mg/L Standard Deviation 0.147	—	13.3 mg/L Standard Deviation 6.11	7.71 mg/L Standard Deviation 4.42	—
Concentrations of REGN10987 in Serum Over Time 0 Days (Pre-dose)	0.0223 mg/L Standard Deviation 0.116	0 mg/L Standard Deviation 0	0 mg/L Standard Deviation 0	0 mg/L Standard Deviation 0	0 mg/L Standard Deviation 0	6.00 mg/L Standard Deviation 30.6	0 mg/L Standard Deviation 0	0.00577 mg/L Standard Deviation 0.0341	—
Concentrations of REGN10987 in Serum Over Time 0 Days (End of Infusion)	144 mg/L Standard Deviation 42.5	39.6 mg/L Standard Deviation 15.5	28.9 mg/L Standard Deviation 26.7	8.60 mg/L Standard Deviation 5.10	1.91 mg/L Standard Deviation 0.687	150 mg/L Standard Deviation 58.0	0.580 mg/L Standard Deviation 0.777	0.232 mg/L Standard Deviation 0.614	—
Concentrations of REGN10987 in Serum Over Time 8 Days	—	—	—	—	—	61.6 mg/L Standard Deviation 12.0	—	—	—
Concentrations of REGN10987 in Serum Over Time 14 Days	40.0 mg/L Standard Deviation 11.2	11.2 mg/L Standard Deviation 3.41	7.20 mg/L Standard Deviation 3.09	2.33 mg/L Standard Deviation 1.37	0.438 mg/L Standard Deviation 0.226	—	33.8 mg/L Standard Deviation 9.51	18.0 mg/L Standard Deviation 6.15	—
Concentrations of REGN10987 in Serum Over Time 22 Days	—	—	—	—	—	35.0 mg/L Standard Deviation 10.5	—	—	—
Concentrations of REGN10987 in Serum Over Time 50 Days	—	—	—	—	—	14.5 mg/L Standard Deviation 4.09	—	—	—
Concentrations of REGN10987 in Serum Over Time 56 Days	9.23 mg/L Standard Deviation 4.97	2.51 mg/L Standard Deviation 1.48	1.55 mg/L Standard Deviation 0.903	0.507 mg/L Standard Deviation 0.453	0.0776 mg/L Standard Deviation 0.138	—	8.02 mg/L Standard Deviation 3.99	4.86 mg/L Standard Deviation 3.07	—
Concentrations of REGN10987 in Serum Over Time 162 Days	—	—	—	—	—	0.566 mg/L Standard Deviation 0.560	—	—	—
Concentrations of REGN10987 in Serum Over Time 168 Days	—	—	—	—	—	—	0.347 mg/L Standard Deviation 0.378	0.251 mg/L Standard Deviation 0.465	—
Concentrations of REGN10987 in Serum Over Time 182 Days	0.400 mg/L Standard Deviation 0.617	0.0401 mg/L Standard Deviation 0.124	0.0408 mg/L Standard Deviation 0.179	0 mg/L Standard Deviation 0	0 mg/L Standard Deviation 0	—	—	—	—

SECONDARY outcome

Timeframe: Up to Day 183

Population: The pharmacokinetics (PK) analysis sets (PKAS) are defined for each study drug separately and includes all subjects who received any study drug and who had at least 1 non-missing result following the first dose of the respective study drug.

Outcome measures

Outcome measures
Measure	Vaccine Only n=27 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=27 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=27 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=30 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=30 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=23 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=34 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 Negative	48.1 Percent of Participants	55.6 Percent of Participants	44.4 Percent of Participants	46.7 Percent of Participants	56.7 Percent of Participants	56.5 Percent of Participants	55.9 Percent of Participants	57.1 Percent of Participants	—
Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 Pre-Existing Immunoreactivity	7.4 Percent of Participants	0 Percent of Participants	3.7 Percent of Participants	3.3 Percent of Participants	3.3 Percent of Participants	8.7 Percent of Participants	0 Percent of Participants	5.7 Percent of Participants	—
Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10987 Treatment-Boosted Response	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants	3.3 Percent of Participants	0 Percent of Participants	0 Percent of Participants	2.9 Percent of Participants	0 Percent of Participants	—

SECONDARY outcome

Timeframe: Up to Day 183

Population: The AAS are defined for each study drug separately and include all treated participants who received any amount of study drug (active \[SAF\]) and had at least 1 non-missing ADA result of respective analyte following the first dose of study drug.

Outcome measures

Outcome measures
Measure	Vaccine Only n=27 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=27 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=27 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=30 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=30 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=23 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=34 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 Negative	66.7 Percent of Participants	59.3 Percent of Participants	44.4 Percent of Participants	30.0 Percent of Participants	36.7 Percent of Participants	91.3 Percent of Participants	70.6 Percent of Participants	62.9 Percent of Participants	—
Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 Pre-Existing Immunoreactivity	0 Percent of Participants	3.7 Percent of Participants	3.7 Percent of Participants	6.7 Percent of Participants	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants	—
Immunogenicity, as Measured by Anti-drug Antibodies (ADA) to REGN10933 Treatment-Boosted Response	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants	0 Percent of Participants	—

SECONDARY outcome

Timeframe: Up to Day 183

Population: The NAbS are defined for each study drug separately and comprises all treated participants (active) that were included in the AAS and tested negative at all ADA sampling times or tested positive at 1 or more postdose ADA sampling times and had at least 1 non-missing postdose NAb result (imputed or analysis result).

Outcome measures

Outcome measures
Measure	Vaccine Only n=27 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=27 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=27 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=30 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=30 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=23 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=34 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 NAb Negative	16 Participants	12 Participants	16 Participants	17 Participants	20 Participants	15 Participants	24 Participants	22 Participants	—
Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10987 NAb Positive	11 Participants	6 Participants	11 Participants	13 Participants	10 Participants	8 Participants	10 Participants	13 Participants	—

SECONDARY outcome

Timeframe: Up to Day 183

Population: The NAbS are defined for each study drug separately and comprises all treated participants (active) that were included in the AAS and tested negative at all ADA sampling times or tested positive at 1 or more postdose ADA sampling times and had at least 1 non-missing postdose NAb result (imputed or analysis result).

Outcome measures

Outcome measures
Measure	Vaccine Only n=27 Participants Vaccine only, no study drug	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=27 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=27 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=30 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=30 Participants REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=23 Participants REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=34 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 Participants REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC
Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 NAb Negative	27 Participants	25 Participants	26 Participants	22 Participants	23 Participants	21 Participants	32 Participants	32 Participants	—
Immunogenicity, as Measured by Neutralizing Antibodies (NAb) to REGN10933 Nab Positive	0 Participants	2 Participants	1 Participants	8 Participants	7 Participants	2 Participants	2 Participants	3 Participants	—

Adverse Events

Vaccine Only Total All

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV

Serious events: 2 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Vaccine Only Total All n=48 participants at risk Vaccine only, no study intervention	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=28 participants at risk REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV n=29 participants at risk REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV n=28 participants at risk REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 participants at risk REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=35 participants at risk REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV n=33 participants at risk REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=31 participants at risk REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 participants at risk REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV
Hepatobiliary disorders Cholelithiasis	2.1% 1/48 • Number of events 1 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/29 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/33 • Up to 401 Days	0.00% 0/31 • Up to 401 Days	0.00% 0/26 • Up to 401 Days
Infections and infestations Diabetic foot infection	2.1% 1/48 • Number of events 1 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/29 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/33 • Up to 401 Days	0.00% 0/31 • Up to 401 Days	0.00% 0/26 • Up to 401 Days
Blood and lymphatic system disorders Anaemia	0.00% 0/48 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/29 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/33 • Up to 401 Days	0.00% 0/31 • Up to 401 Days	3.8% 1/26 • Number of events 1 • Up to 401 Days
Gastrointestinal disorders Gastritis	0.00% 0/48 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/29 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	2.9% 1/35 • Number of events 1 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/33 • Up to 401 Days	0.00% 0/31 • Up to 401 Days	0.00% 0/26 • Up to 401 Days
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/48 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/29 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/33 • Up to 401 Days	0.00% 0/31 • Up to 401 Days	3.8% 1/26 • Number of events 1 • Up to 401 Days

Other adverse events

Other adverse events
Measure	Vaccine Only Total All n=48 participants at risk Vaccine only, no study intervention	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV n=28 participants at risk REGN10933+REGN10987 + Vaccine 1200 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV n=29 participants at risk REGN10933+REGN10987 + Vaccine 300 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV n=28 participants at risk REGN10933+REGN10987 + Vaccine 150 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC n=35 participants at risk REGN10933+REGN10987 + Vaccine 1200 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC n=35 participants at risk REGN10933+REGN10987 + Vaccine 600 mg Day 1 SC	REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV n=33 participants at risk REGN10933+REGN10987 + Vaccine 48 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV n=31 participants at risk REGN10933+REGN10987 + Vaccine 12 mg Day 1 IV	REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV n=26 participants at risk REGN10933+REGN10987 + Vaccine 1200 mg Day 7 IV
Infections and infestations COVID-19	10.4% 5/48 • Number of events 5 • Up to 401 Days	25.0% 7/28 • Number of events 8 • Up to 401 Days	10.3% 3/29 • Number of events 3 • Up to 401 Days	10.7% 3/28 • Number of events 4 • Up to 401 Days	20.0% 7/35 • Number of events 7 • Up to 401 Days	17.1% 6/35 • Number of events 6 • Up to 401 Days	0.00% 0/33 • Up to 401 Days	19.4% 6/31 • Number of events 6 • Up to 401 Days	11.5% 3/26 • Number of events 3 • Up to 401 Days
Infections and infestations Asymptomatic COVID-19	6.2% 3/48 • Number of events 3 • Up to 401 Days	7.1% 2/28 • Number of events 2 • Up to 401 Days	13.8% 4/29 • Number of events 4 • Up to 401 Days	32.1% 9/28 • Number of events 9 • Up to 401 Days	17.1% 6/35 • Number of events 6 • Up to 401 Days	20.0% 7/35 • Number of events 7 • Up to 401 Days	12.1% 4/33 • Number of events 4 • Up to 401 Days	12.9% 4/31 • Number of events 4 • Up to 401 Days	3.8% 1/26 • Number of events 1 • Up to 401 Days
Infections and infestations Cellulitis	0.00% 0/48 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/29 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	2.9% 1/35 • Number of events 1 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/33 • Up to 401 Days	6.5% 2/31 • Number of events 2 • Up to 401 Days	0.00% 0/26 • Up to 401 Days
Infections and infestations Upper respiratory tract infection	0.00% 0/48 • Up to 401 Days	7.1% 2/28 • Number of events 2 • Up to 401 Days	3.4% 1/29 • Number of events 1 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	2.9% 1/35 • Number of events 1 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/33 • Up to 401 Days	0.00% 0/31 • Up to 401 Days	0.00% 0/26 • Up to 401 Days
Nervous system disorders Headache	6.2% 3/48 • Number of events 4 • Up to 401 Days	3.6% 1/28 • Number of events 1 • Up to 401 Days	3.4% 1/29 • Number of events 1 • Up to 401 Days	3.6% 1/28 • Number of events 1 • Up to 401 Days	5.7% 2/35 • Number of events 2 • Up to 401 Days	11.4% 4/35 • Number of events 5 • Up to 401 Days	9.1% 3/33 • Number of events 3 • Up to 401 Days	9.7% 3/31 • Number of events 3 • Up to 401 Days	3.8% 1/26 • Number of events 2 • Up to 401 Days
General disorders Injection site reaction	4.2% 2/48 • Number of events 2 • Up to 401 Days	7.1% 2/28 • Number of events 3 • Up to 401 Days	3.4% 1/29 • Number of events 1 • Up to 401 Days	3.6% 1/28 • Number of events 2 • Up to 401 Days	20.0% 7/35 • Number of events 8 • Up to 401 Days	34.3% 12/35 • Number of events 17 • Up to 401 Days	3.0% 1/33 • Number of events 1 • Up to 401 Days	3.2% 1/31 • Number of events 1 • Up to 401 Days	19.2% 5/26 • Number of events 6 • Up to 401 Days
General disorders Chills	0.00% 0/48 • Up to 401 Days	3.6% 1/28 • Number of events 1 • Up to 401 Days	0.00% 0/29 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	2.9% 1/35 • Number of events 1 • Up to 401 Days	6.1% 2/33 • Number of events 2 • Up to 401 Days	0.00% 0/31 • Up to 401 Days	3.8% 1/26 • Number of events 1 • Up to 401 Days
General disorders Pyrexia	0.00% 0/48 • Up to 401 Days	3.6% 1/28 • Number of events 1 • Up to 401 Days	0.00% 0/29 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	8.6% 3/35 • Number of events 4 • Up to 401 Days	6.1% 2/33 • Number of events 2 • Up to 401 Days	3.2% 1/31 • Number of events 1 • Up to 401 Days	7.7% 2/26 • Number of events 3 • Up to 401 Days
Vascular disorders Hypertension	2.1% 1/48 • Number of events 1 • Up to 401 Days	3.6% 1/28 • Number of events 1 • Up to 401 Days	3.4% 1/29 • Number of events 1 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	2.9% 1/35 • Number of events 1 • Up to 401 Days	6.1% 2/33 • Number of events 2 • Up to 401 Days	0.00% 0/31 • Up to 401 Days	3.8% 1/26 • Number of events 1 • Up to 401 Days
Gastrointestinal disorders Nausea	0.00% 0/48 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	3.4% 1/29 • Number of events 1 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	5.7% 2/35 • Number of events 2 • Up to 401 Days	3.0% 1/33 • Number of events 1 • Up to 401 Days	0.00% 0/31 • Up to 401 Days	0.00% 0/26 • Up to 401 Days
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/48 • Up to 401 Days	7.1% 2/28 • Number of events 2 • Up to 401 Days	3.4% 1/29 • Number of events 1 • Up to 401 Days	0.00% 0/28 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	0.00% 0/35 • Up to 401 Days	3.0% 1/33 • Number of events 1 • Up to 401 Days	6.5% 2/31 • Number of events 2 • Up to 401 Days	0.00% 0/26 • Up to 401 Days

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 18447346643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER