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

Phase-I <br/ >1.any adverse reactions <br/ >2.any solicited symptoms <br/ >3.any unsolicited adverse events <br/ >4.Serious and other medically attended adverse events <br/ >Phase-II <br/ >1.Virus neutralizing antibody (NAb) assay against SARS-CoV-2 virus <br/ >2.Seroconversion rates in terms of proportion of subjects with â?¥4-fold increase in neutralizing antibodies <br/ >3.Geometric mean titres and Geometric mean fold rise in neutralizing antibodies <br/ >Timepoint: Phase-I <br/ >1.within 2 hours of immediate post vaccination period; <br/ >2.within 7 consecutive days after each dose captured through subject diary; <br/ >3.at 6 months and 12 months post 2nd dose. <br/ >4.at 6 months and 12 months post 2nd dose <br/ > <br/ >Phase-II <br/ >1.at baseline; 28; 42; 56 days and again at 6 months and 12 months post 2nd dose. <br/ >2.from baseline <br/ >3.from baseline <br/ >

Phase-I <br/ >1.any adverse reactions <br/ >2.any solicited symptoms <br/ >3.any unsolicited adverse events <br/ >4.Serious and other medically attended adverse events <br/ >Phase-II <br/ >1.Virus neutralizing antibody (NAb) assay against SARS-CoV-2 virus <br/ >2.Seroconversion rates in terms of proportion of subjects with â?¥4-fold increase in neutralizing antibodies <br/ >3.Geometric mean titres and Geometric mean fold rise in neutralizing antibodies <br/ >Timepoint: Phase-I <br/ >1.within 2 hours of immediate post vaccination period; <br/ >2.within 7 consecutive days after each dose captured through subject diary; <br/ >3.at 6 months and 12 months post 2nd dose. <br/ >4.at 6 months and 12 months post 2nd dose <br/ > <br/ >Phase-II <br/ >1.at baseline; 28; 42; 56 days and again at 6 months and 12 months post 2nd dose. <br/ >2.from baseline <br/ >3.from baseline <br/ >

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

N/A

N/A

Dec. 5, 2020, 12:45 a.m. oms

Phase-I <br/ >1.any adverse reactions <br/ >2.any solicited symptoms <br/ >3.any unsolicited adverse events <br/ >4.Serious and other medically attended adverse events <br/ >Phase-II <br/ >1.Virus neutralizing antibody (NAb) assay against SARS-CoV-2 virus <br/ >2.Seroconversion rates in terms of proportion of subjects with â?¥4-fold increase in neutralizing antibodies <br/ >3.Geometric mean titres and Geometric mean fold rise in neutralizing antibodies <br/ >Timepoint: Phase-I <br/ >1.within 2 hours of immediate post vaccination period; <br/ >2.within 7 consecutive days after each dose captured through subject diary; <br/ >3.at 6 months and 12 months post 2nd dose. <br/ >4.at 6 months and 12 months post 2nd dose <br/ > <br/ >Phase-II <br/ >1.at baseline; 28; 42; 56 days and again at 6 months and 12 months post 2nd dose. <br/ >2.from baseline <br/ >3.from baseline <br/ >

Phase-I <br/ >1.any adverse reactions <br/ >2.any solicited symptoms <br/ >3.any unsolicited adverse events <br/ >4.Serious and other medically attended adverse events <br/ >Phase-II <br/ >1.Virus neutralizing antibody (NAb) assay against SARS-CoV-2 virus <br/ >2.Seroconversion rates in terms of proportion of subjects with â?¥4-fold increase in neutralizing antibodies <br/ >3.Geometric mean titres and Geometric mean fold rise in neutralizing antibodies <br/ >Timepoint: Phase-I <br/ >1.within 2 hours of immediate post vaccination period; <br/ >2.within 7 consecutive days after each dose captured through subject diary; <br/ >3.at 6 months and 12 months post 2nd dose. <br/ >4.at 6 months and 12 months post 2nd dose <br/ > <br/ >Phase-II <br/ >1.at baseline; 28; 42; 56 days and again at 6 months and 12 months post 2nd dose. <br/ >2.from baseline <br/ >3.from baseline <br/ >