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March 10, 2025, 10:20 a.m. usa

Geometric Mean Fold Rise (GMFR) of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815;Geometric Mean Titer (GMT) of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);GMFR of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815;GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273;GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815;GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815;Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation;Number of Participants With Solicited Local and Systemic ARs;Number of Participants With Unsolicited AEs;Seroresponse Rate (SRR) (Based on Pre-vaccination Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);SRR (Based on Pre-booster Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);SRR (Based on Pre-booster Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273;SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);SRR (Based on Pre-vaccination Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273;SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815;SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815;SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815;SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815;SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

Geometric Mean Fold Rise (GMFR) of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815;Geometric Mean Titer (GMT) of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);GMFR of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815;GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273;GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815;GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815;Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation;Number of Participants With Solicited Local and Systemic ARs;Number of Participants With Unsolicited AEs;Seroresponse Rate (SRR) (Based on Pre-vaccination Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);SRR (Based on Pre-booster Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);SRR (Based on Pre-booster Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273;SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);SRR (Based on Pre-vaccination Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1);SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273;SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815;SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815;SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815;SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815;SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273);SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)

May 30, 2023, 3:29 p.m. usa

Geometric mean fold rise (GMFR) of Omicron-Specific Antibody (For Part J only) at Day 15;Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Antibody at Day 29;GMT of Omicron-Specific Antibody at Day 91 (For Part G only);GMT of Omicron-Specific Antibody (For Part J only) at Day 15;GMT of Omicron-Specific Antibody (For Parts F, G, H and J only) at Day 29;GMT of SARS-CoV-2-Specific Antibody at Day 91 (For Part G only);Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs);Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Seroresponse Rate of Vaccine Recipients at Day 15 (For Part J only);Seroresponse Rate of Vaccine Recipients at Day 29;Seroresponse Rate of Vaccine Recipients at Day 91 (For Part G only)

Geometric mean fold rise (GMFR) of Omicron-Specific Antibody (For Part J only) at Day 15;Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Antibody at Day 29;GMT of Omicron-Specific Antibody at Day 91 (For Part G only);GMT of Omicron-Specific Antibody (For Part J only) at Day 15;GMT of Omicron-Specific Antibody (For Parts F, G, H and J only) at Day 29;GMT of SARS-CoV-2-Specific Antibody at Day 91 (For Part G only);Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs);Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Seroresponse Rate of Vaccine Recipients at Day 15 (For Part J only);Seroresponse Rate of Vaccine Recipients at Day 29;Seroresponse Rate of Vaccine Recipients at Day 91 (For Part G only)

Sept. 9, 2022, midnight usa

Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Antibody at Day 29;GMT of Omicron-Specific Antibody at Day 91 (For Part G only);GMT of Omicron-Specific Antibody (For Parts F, G, and H only) at Day 29;GMT of SARS-CoV-2-Specific Antibody at Day 91 (For Part G only);Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs);Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Seroresponse Rate of Vaccine Recipients at Day 29;Seroresponse Rate of Vaccine Recipients at Day 91 (For Part G only)

Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Antibody at Day 29;GMT of Omicron-Specific Antibody at Day 91 (For Part G only);GMT of Omicron-Specific Antibody (For Parts F, G, and H only) at Day 29;GMT of SARS-CoV-2-Specific Antibody at Day 91 (For Part G only);Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs);Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Seroresponse Rate of Vaccine Recipients at Day 29;Seroresponse Rate of Vaccine Recipients at Day 91 (For Part G only)

May 6, 2022, 5 a.m. usa

Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Antibody at Day 29;GMT of Omicron-Specific Antibody at Day 91 (For Part G only);GMT of Omicron-Specific Antibody (For Parts F and G only) at Day 29;GMT of SARS-CoV-2-Specific Antibody at Day 91 (For Part G only);Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs);Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Seroresponse Rate of Vaccine Recipients at Day 29;Seroresponse Rate of Vaccine Recipients at Day 91 (For Part G only)

Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Antibody at Day 29;GMT of Omicron-Specific Antibody at Day 91 (For Part G only);GMT of Omicron-Specific Antibody (For Parts F and G only) at Day 29;GMT of SARS-CoV-2-Specific Antibody at Day 91 (For Part G only);Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs);Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Seroresponse Rate of Vaccine Recipients at Day 29;Seroresponse Rate of Vaccine Recipients at Day 91 (For Part G only)

June 17, 2021, 12:32 a.m. usa

Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Antibody;Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs);Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Seroresponse Rate of Vaccine Recipients

Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Antibody;Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs);Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Seroresponse Rate of Vaccine Recipients