Created at Source Raw Value Validated value
May 20, 2021, 1:30 a.m. eu

First occurrence of any RT-PCR-confirmed COVID-19 of any severity with onset at least 14 days after the second study vaccination in subjects without evidence of prior SARS-CoV-2 infection. Local and systemic solicited AEs reported within 7 days after each study vaccination (in Phase 2 subjects) Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 43 (in Phase 2 subjects) SAEs, AEs leading to early termination from the study, MAAEs, and AESIs during the entire study period (in all subjects).

First occurrence of any RT-PCR-confirmed COVID-19 of any severity with onset at least 14 days after the second study vaccination in subjects without evidence of prior SARS-CoV-2 infection. Local and systemic solicited AEs reported within 7 days after each study vaccination (in Phase 2 subjects) Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 43 (in Phase 2 subjects) SAEs, AEs leading to early termination from the study, MAAEs, and AESIs during the entire study period (in all subjects).