Created at Source Raw Value Validated value
April 8, 2022, 3:30 p.m. oms

Immunogenicity at baseline and day 28 after booster dose Measure Anti-S IgG geometric mean titer;Immunogenicity at baseline and day 28 after booster dose Measure Geometric mean of fold rising (GMFR) in anti-S-RBD IgG;Immunogenicity at baseline and 28 days after booster dose Measure Percentage of seroconversion response from the increase of Anti-S IgG;Immunogenicity at baseline and day 28 after booster dose Measure GMT in NT50 dilution by SARS-CoV-2 pseudovirus neutralisation assay (PVNT) to wild type; Delta and Omicron VOC;Immunogenicity at baseline and day 28 after booster dose Measure GMT in SARS-CoV-2 Variants Neutralizing Antibody by SVNT against Wild type (Euroimmun) Delta (BIOTEC) Omicron Variant (cPass);Immunogenicity at baseline and day 28 after booster dose Measure percentage of NT50 dilution by SARS-CoV-2 pseudovirus neutralisation assay (PVNT) to wild type; Delta and Omicron VOC;Immunogenicity at baseline and day 28 after booster dose Measure percentage of SARS-CoV-2 Variants Neutralizing Antibody by SVNT against Wild type (Euroimmun) Delta (BIOTEC) Omicron Variant (cPass);Immunogenicity at baseline and day 28 after booster dose Measure GMT in interferon gamma of reactive T lymphocytes response against SARS-CoV2 protein which measured by interferon gamma release assay (IGRA);Safety and tolerability for 7 days following booster vaccination Patient report number and severity of solicited local and systemic of solicited local and systemic AEs in AE form. ;Safety and tolerability for 14 days following booster vaccination Patient report number and severity of solicited local and systemic of solicited local and systemic AEs in AE form;Safety and tolerability throughout the study Monitoring number and severity of solicited local and systemic of solicited local and systemic AEs.

Immunogenicity at baseline and day 28 after booster dose Measure Anti-S IgG geometric mean titer;Immunogenicity at baseline and day 28 after booster dose Measure Geometric mean of fold rising (GMFR) in anti-S-RBD IgG;Immunogenicity at baseline and 28 days after booster dose Measure Percentage of seroconversion response from the increase of Anti-S IgG;Immunogenicity at baseline and day 28 after booster dose Measure GMT in NT50 dilution by SARS-CoV-2 pseudovirus neutralisation assay (PVNT) to wild type; Delta and Omicron VOC;Immunogenicity at baseline and day 28 after booster dose Measure GMT in SARS-CoV-2 Variants Neutralizing Antibody by SVNT against Wild type (Euroimmun) Delta (BIOTEC) Omicron Variant (cPass);Immunogenicity at baseline and day 28 after booster dose Measure percentage of NT50 dilution by SARS-CoV-2 pseudovirus neutralisation assay (PVNT) to wild type; Delta and Omicron VOC;Immunogenicity at baseline and day 28 after booster dose Measure percentage of SARS-CoV-2 Variants Neutralizing Antibody by SVNT against Wild type (Euroimmun) Delta (BIOTEC) Omicron Variant (cPass);Immunogenicity at baseline and day 28 after booster dose Measure GMT in interferon gamma of reactive T lymphocytes response against SARS-CoV2 protein which measured by interferon gamma release assay (IGRA);Safety and tolerability for 7 days following booster vaccination Patient report number and severity of solicited local and systemic of solicited local and systemic AEs in AE form. ;Safety and tolerability for 14 days following booster vaccination Patient report number and severity of solicited local and systemic of solicited local and systemic AEs in AE form;Safety and tolerability throughout the study Monitoring number and severity of solicited local and systemic of solicited local and systemic AEs.