Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1.Proportion of subjects with solicited adverse reactions/symptoms <br/ >2.Proportion of subjects with unsolicited adverse events (AEs) <br/ >3.SAEs & MAAE in all subjects. <br/ >1.Anti-RBD IgG antibodies in terms of ratio of IgG1 to IgG4 anti-RBD titres. <br/ >2.Neutralizing antibody titre <br/ >3.Immunogenicity in terms of GMC/T <br/ >4.Proportion of subjects seroconverted in terms of �2-fold & �4-fold rise <br/ >5.Cell mediated immunity assessment in terms of cytokine expression from stimulated PBMCs (INF-γ; IL-4) <br/ >Timepoint: 1.during first 60 minutes of post vaccination and subsequent 7 days. <br/ >2.28-day follow-up period after each dose. <br/ >3.At 6 and 12months post 2nd dose. <br/ >1.at day 42 vs baseline. <br/ >2.at baseline and again at day 42. <br/ >3.at baseline and again at day 42. <br/ >4.in baseline seronegative subjects and �2-fold rise in baseline seropositive subjects along with their GMFR at day 42 <br/ >5.at baseline and at day 42

1.Proportion of subjects with solicited adverse reactions/symptoms <br/ >2.Proportion of subjects with unsolicited adverse events (AEs) <br/ >3.SAEs & MAAE in all subjects. <br/ >1.Anti-RBD IgG antibodies in terms of ratio of IgG1 to IgG4 anti-RBD titres. <br/ >2.Neutralizing antibody titre <br/ >3.Immunogenicity in terms of GMC/T <br/ >4.Proportion of subjects seroconverted in terms of �2-fold & �4-fold rise <br/ >5.Cell mediated immunity assessment in terms of cytokine expression from stimulated PBMCs (INF-γ; IL-4) <br/ >Timepoint: 1.during first 60 minutes of post vaccination and subsequent 7 days. <br/ >2.28-day follow-up period after each dose. <br/ >3.At 6 and 12months post 2nd dose. <br/ >1.at day 42 vs baseline. <br/ >2.at baseline and again at day 42. <br/ >3.at baseline and again at day 42. <br/ >4.in baseline seronegative subjects and �2-fold rise in baseline seropositive subjects along with their GMFR at day 42 <br/ >5.at baseline and at day 42

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

Sept. 8, 2021, 1:30 a.m. oms

1.Proportion of subjects with solicited adverse reactions/symptoms <br/ >2.Proportion of subjects with unsolicited adverse events (AEs) <br/ >3.SAEs & MAAE in all subjects. <br/ >1.Anti-RBD IgG antibodies in terms of ratio of IgG1 to IgG4 anti-RBD titres. <br/ >2.Neutralizing antibody titre <br/ >3.Immunogenicity in terms of GMC/T <br/ >4.Proportion of subjects seroconverted in terms of �2-fold & �4-fold rise <br/ >5.Cell mediated immunity assessment in terms of cytokine expression from stimulated PBMCs (INF-γ; IL-4) <br/ >Timepoint: 1.during first 60 minutes of post vaccination and subsequent 7 days. <br/ >2.28-day follow-up period after each dose. <br/ >3.At 6 and 12months post 2nd dose. <br/ >1.at day 42 vs baseline. <br/ >2.at baseline and again at day 42. <br/ >3.at baseline and again at day 42. <br/ >4.in baseline seronegative subjects and �2-fold rise in baseline seropositive subjects along with their GMFR at day 42 <br/ >5.at baseline and at day 42

1.Proportion of subjects with solicited adverse reactions/symptoms <br/ >2.Proportion of subjects with unsolicited adverse events (AEs) <br/ >3.SAEs & MAAE in all subjects. <br/ >1.Anti-RBD IgG antibodies in terms of ratio of IgG1 to IgG4 anti-RBD titres. <br/ >2.Neutralizing antibody titre <br/ >3.Immunogenicity in terms of GMC/T <br/ >4.Proportion of subjects seroconverted in terms of �2-fold & �4-fold rise <br/ >5.Cell mediated immunity assessment in terms of cytokine expression from stimulated PBMCs (INF-γ; IL-4) <br/ >Timepoint: 1.during first 60 minutes of post vaccination and subsequent 7 days. <br/ >2.28-day follow-up period after each dose. <br/ >3.At 6 and 12months post 2nd dose. <br/ >1.at day 42 vs baseline. <br/ >2.at baseline and again at day 42. <br/ >3.at baseline and again at day 42. <br/ >4.in baseline seronegative subjects and �2-fold rise in baseline seropositive subjects along with their GMFR at day 42 <br/ >5.at baseline and at day 42