Created at Source Raw Value Validated value
Oct. 21, 2021, 10 a.m. oms

1. SARS-COV-2 IgG-specific antibody concentrations measured by ELISA from blood samples collected from vaccinated maternal subjects at delivery 2. Occurrence of solicited local and general adverse events (AEs) that occur during a 7-day follow-up period after each vaccination (i.e.; the day of vaccination and 6 subsequent days); measured using diary data entry (solicited AE) from Day 0 to Day 6 3. Occurrence of unsolicited AEs that occur during a 30-day follow-up period after vaccination (i.e.; the day of vaccination and 29 subsequent days); measured using diary data entry (unsolicited AE) from Day 0 to Day 29

1. SARS-COV-2 IgG-specific antibody concentrations measured by ELISA from blood samples collected from vaccinated maternal subjects at delivery 2. Occurrence of solicited local and general adverse events (AEs) that occur during a 7-day follow-up period after each vaccination (i.e.; the day of vaccination and 6 subsequent days); measured using diary data entry (solicited AE) from Day 0 to Day 6 3. Occurrence of unsolicited AEs that occur during a 30-day follow-up period after vaccination (i.e.; the day of vaccination and 29 subsequent days); measured using diary data entry (unsolicited AE) from Day 0 to Day 29