Created at Source Raw Value Validated value
May 5, 2022, 11:30 p.m. oms

Safety (Phase II ) <br/ >Occurrence and severity of local and systemic reactogenicity adverse events; <br/ >unsolicited events and serious adverse events (SAE) <br/ > <br/ >Immunogenicity (Phase II and III) <br/ >Age group: 12 - Less than 18 years <br/ >Geometric mean titer (GMT) of SARS-CoV-2 specific serum neutralizing antibody levels using live virus [Plaque Reduction Neutralization Test (PRNT)] <br/ > <br/ >Immunogenicity (Phase II and III) <br/ >Age group: 5 - 11 years <br/ >GMT as measured by IgG-ELISA against SARS-CoV-2 Spike proteinTimepoint: Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. <br/ > <br/ > <br/ > <br/ >At Day 57. <br/ > <br/ > <br/ > <br/ > <br/ > <br/ >At Day 43. <br/ > <br/ >

Safety (Phase II ) <br/ >Occurrence and severity of local and systemic reactogenicity adverse events; <br/ >unsolicited events and serious adverse events (SAE) <br/ > <br/ >Immunogenicity (Phase II and III) <br/ >Age group: 12 - Less than 18 years <br/ >Geometric mean titer (GMT) of SARS-CoV-2 specific serum neutralizing antibody levels using live virus [Plaque Reduction Neutralization Test (PRNT)] <br/ > <br/ >Immunogenicity (Phase II and III) <br/ >Age group: 5 - 11 years <br/ >GMT as measured by IgG-ELISA against SARS-CoV-2 Spike proteinTimepoint: Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. <br/ > <br/ > <br/ > <br/ >At Day 57. <br/ > <br/ > <br/ > <br/ > <br/ > <br/ >At Day 43. <br/ > <br/ >