Created at Source Raw Value Validated value
Oct. 21, 2021, 10 a.m. oms

Safety:1. The incidences; severity; and investigator-assessed causality of immediate adverse events (AEs) that occur within 30 minutes of first (Day 0) and second (Day 21) injections.2. The incidences and severity of the following solicited AEs that develop within 7 days of first (Day 0) and second (Day 21) injections: (i) local AEs (injection site erythema; injection site swelling; injection site induration; and injection site pain) and (ii) systemic AEs (fever; headache; fatigue; muscle aches; joint aches; chills; a feeling of general discomfort; swelling in the axilla; and swelling in the neck).3. The incidences; severity; and investigator-assessed causality of unsolicited AEs that develop within 21 days of first (Day 0) and second (Day 21) injections.4. The incidences of serious AEs (SAEs); medically attended AEs (MAAEs); AEs leading to withdrawal; AEs of special interest (AESIs); and deaths up to 21 days following first (Day 0) and second (Day 21) injections. AESIs include vaccine-associated enhanced diseases (VAED); hypersensitivity reactions; and potential immune-mediated diseases (pIMDs)Immunogenicity:1. SARS-CoV-2 neutralizing antibody (Nab) responses will be analyzed on Days 0; 21; and 42 using the following parameters: geometric mean antibody titer (GMT); seroconversion (SC) rate; and geometric mean fold rise (GMFR);2. SARS-CoV-2-specific T helper 1 (Th1) cell-mediated immune (CMI) responses will be measured on Days 0; 21; and 42 using the interferon (IFN)-gamma enzyme-linked immunospot (ELISpot) assay;3. SARS-CoV-2-specific T helper 2 (Th2) CMI responses will be measured on Days 0; 21; and 42 using the interleukin (IL)-4 ELISpot assay.

Safety:1. The incidences; severity; and investigator-assessed causality of immediate adverse events (AEs) that occur within 30 minutes of first (Day 0) and second (Day 21) injections.2. The incidences and severity of the following solicited AEs that develop within 7 days of first (Day 0) and second (Day 21) injections: (i) local AEs (injection site erythema; injection site swelling; injection site induration; and injection site pain) and (ii) systemic AEs (fever; headache; fatigue; muscle aches; joint aches; chills; a feeling of general discomfort; swelling in the axilla; and swelling in the neck).3. The incidences; severity; and investigator-assessed causality of unsolicited AEs that develop within 21 days of first (Day 0) and second (Day 21) injections.4. The incidences of serious AEs (SAEs); medically attended AEs (MAAEs); AEs leading to withdrawal; AEs of special interest (AESIs); and deaths up to 21 days following first (Day 0) and second (Day 21) injections. AESIs include vaccine-associated enhanced diseases (VAED); hypersensitivity reactions; and potential immune-mediated diseases (pIMDs)Immunogenicity:1. SARS-CoV-2 neutralizing antibody (Nab) responses will be analyzed on Days 0; 21; and 42 using the following parameters: geometric mean antibody titer (GMT); seroconversion (SC) rate; and geometric mean fold rise (GMFR);2. SARS-CoV-2-specific T helper 1 (Th1) cell-mediated immune (CMI) responses will be measured on Days 0; 21; and 42 using the interferon (IFN)-gamma enzyme-linked immunospot (ELISpot) assay;3. SARS-CoV-2-specific T helper 2 (Th2) CMI responses will be measured on Days 0; 21; and 42 using the interleukin (IL)-4 ELISpot assay.