Created at Source Raw Value Validated value
May 14, 2022, 7 a.m. usa

Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose;Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43;Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose;Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose;Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43;Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial;Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose;Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial;Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose;Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43;Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43

Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After Any Dose;Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein RBD Antibodies on Day 43;Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Any Dose;Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose;Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 43;Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial;Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose;Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial;Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Any Dose;Subset Participants: GMTs of Serum SARS-CoV-2 Neutralizing Antibodies on Day 43;Subset Participants: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 43

April 28, 2021, 12:31 a.m. usa

Duration of Solicited Local Adverse Events (AEs);Duration of Solicited Systemic Adverse Events (AEs);Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies;Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies;Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum;Individual SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD)-Specific Antibody Levels in Serum;Intensity of Solicited Local Adverse Events (AEs) per US Food and Drug Administration (FDA) Toxicity Grading Scale;Intensity of Solicited Systemic Adverse Events (AEs) per US Food and Drug Administration (FDA) Toxicity Grading Scale;Intensity of Unsolicited Adverse Events (AEs) per the Investigator's Assessment;Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies;Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies;Number of Participants Who Experience an Adverse Event of Special Interest (AESI);Number of Participants Who Experience an Unsolicited Adverse Event (AE);Number of Participants Who Experience a Serious Adverse Event (SAE);Number of Participants Who Experience a Solicited Local Adverse Event (AE);Number of Participants Who Experience a Solicited Systemic Adverse Event (AE);Number of Participants Who Experience a Treatment-Related Adverse Event of Special Interest (AESI);Number of Participants Who Experience a Treatment-Related Serious Adverse Event (SAE);Number of Participants Who Experience a Treatment-Related Solicited Systemic Adverse Event (AE);Number of Participants Who Experience a Treatment-Related Unsolicited Adverse Event (AE)

Duration of Solicited Local Adverse Events (AEs);Duration of Solicited Systemic Adverse Events (AEs);Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies;Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies;Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum;Individual SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD)-Specific Antibody Levels in Serum;Intensity of Solicited Local Adverse Events (AEs) per US Food and Drug Administration (FDA) Toxicity Grading Scale;Intensity of Solicited Systemic Adverse Events (AEs) per US Food and Drug Administration (FDA) Toxicity Grading Scale;Intensity of Unsolicited Adverse Events (AEs) per the Investigator's Assessment;Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies;Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies;Number of Participants Who Experience an Adverse Event of Special Interest (AESI);Number of Participants Who Experience an Unsolicited Adverse Event (AE);Number of Participants Who Experience a Serious Adverse Event (SAE);Number of Participants Who Experience a Solicited Local Adverse Event (AE);Number of Participants Who Experience a Solicited Systemic Adverse Event (AE);Number of Participants Who Experience a Treatment-Related Adverse Event of Special Interest (AESI);Number of Participants Who Experience a Treatment-Related Serious Adverse Event (SAE);Number of Participants Who Experience a Treatment-Related Solicited Systemic Adverse Event (AE);Number of Participants Who Experience a Treatment-Related Unsolicited Adverse Event (AE)