High dose - (1200 mg arms)

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)

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

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)

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%

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)

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)

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%

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

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)

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%

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

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)

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%

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

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%

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)

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)

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

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

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.

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.

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).

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).

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).

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).

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).

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

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

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.

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.

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.

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.

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).

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).