Created at Source Raw Value Validated value
Jan. 5, 2025, 10:16 p.m. usa

Number of Adult Participants With Adverse Events of Special Interest (AESIs) From First Vaccination Until EOS;Number of Adult Participants With AEs Leading to Study Discontinuation;Number of Adult Participants With Medically Attended Adverse Events (MAAEs) Until 6 Months Post First Vaccination;Number of Adult Participants With Serious Adverse Events (SAEs) From First Vaccination Until End of the Study (EOS);Number of Adult Participants With Solicited Local Adverse Events (AEs) for 7 Days Post First Vaccination;Number of Adult Participants With Solicited Systemic AEs for 7 Days Post First Vaccination;Number of Adult Participants With Unsolicited AEs for 28 Days Post First Vaccination;Serological Response to Vaccination as Measured by S-Enzyme-linked Immunosorbent Assay (S-ELISA) in Adult Participants 28 Days Post First Vaccination

Number of Adult Participants With Adverse Events of Special Interest (AESIs) From First Vaccination Until EOS;Number of Adult Participants With AEs Leading to Study Discontinuation;Number of Adult Participants With Medically Attended Adverse Events (MAAEs) Until 6 Months Post First Vaccination;Number of Adult Participants With Serious Adverse Events (SAEs) From First Vaccination Until End of the Study (EOS);Number of Adult Participants With Solicited Local Adverse Events (AEs) for 7 Days Post First Vaccination;Number of Adult Participants With Solicited Systemic AEs for 7 Days Post First Vaccination;Number of Adult Participants With Unsolicited AEs for 28 Days Post First Vaccination;Serological Response to Vaccination as Measured by S-Enzyme-linked Immunosorbent Assay (S-ELISA) in Adult Participants 28 Days Post First Vaccination

July 1, 2022, 11 p.m. usa

Number of Participants with Adverse Events of Special Interest (AESIs);Number of Participants with AEs leading to Discontinuation;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination or Until Resolution;Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination or Until Resolution;Number of Participants with Unsolicited AEs;Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After Vaccination

Number of Participants with Adverse Events of Special Interest (AESIs);Number of Participants with AEs leading to Discontinuation;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination or Until Resolution;Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination or Until Resolution;Number of Participants with Unsolicited AEs;Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After Vaccination

June 9, 2022, 4 p.m. usa

None

Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination or Until Resolution [ Time Frame: 7 days after vaccination or until resolution (Up to Day 8) ] Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post vaccination or until resolution. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site. Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination or Until Resolution [ Time Frame: 7 days after vaccination or until resolution (Up to Day 8) ] Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) or until resolution for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia. Number of Participants with Unsolicited AEs [ Time Frame: 28 days after vaccination (Up to Day 29) ] Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 16 months ] SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 16 months ] Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI. Number of Participants with Medically-attended Adverse Events (MAAEs) [ Time Frame: 6 months after vaccination (Up to Day 183) ] MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs. Number of Participants with AEs leading to Discontinuation [ Time Frame: Up to 16 months ] An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After Vaccination [ Time Frame: 28 days after vaccination (Day 29) ] Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/milliliter [EU/mL]), 28 days after vaccination will be reported.

April 23, 2022, 1:30 a.m. usa

Number of Participants with Adverse Events of Special Interest (AESIs);Number of Participants with AEs leading to Discontinuation;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination or Until Resolution;Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination or Until Resolution;Number of Participants with Unsolicited AEs;Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After Vaccination

Number of Participants with Adverse Events of Special Interest (AESIs);Number of Participants with AEs leading to Discontinuation;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination or Until Resolution;Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination or Until Resolution;Number of Participants with Unsolicited AEs;Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After Vaccination

Jan. 16, 2022, 10:30 a.m. usa

Number of Participants with Adverse Events of Special Interest (AESIs);Number of Participants with AEs leading to Discontinuation;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each vaccination or Until Resolution;Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination or Until Resolution;Number of Participants with Unsolicited AEs;Serological Response to Vaccination as Measured by ELISA 14 Days After the Second Vaccination;Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After the First Vaccination

Number of Participants with Adverse Events of Special Interest (AESIs);Number of Participants with AEs leading to Discontinuation;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each vaccination or Until Resolution;Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination or Until Resolution;Number of Participants with Unsolicited AEs;Serological Response to Vaccination as Measured by ELISA 14 Days After the Second Vaccination;Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After the First Vaccination

Aug. 6, 2021, 3 p.m. usa

Number of Participants with Adverse Events of Special Interest (AESIs);Number of Participants with AEs leading to Discontinuation;Number of Participants with Antibody Geometric Mean Concentration (GMC) 28 Days After the First Vaccination;Number of Participants with Antibody GMC 14 Days After the Second Vaccination;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each vaccination or Until Resolution;Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination or Until Resolution;Number of Participants with Unsolicited AEs;Serological Response to Vaccination as Measured by ELISA 14 Days After the Second Vaccination;Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After the First Vaccination

Number of Participants with Adverse Events of Special Interest (AESIs);Number of Participants with AEs leading to Discontinuation;Number of Participants with Antibody Geometric Mean Concentration (GMC) 28 Days After the First Vaccination;Number of Participants with Antibody GMC 14 Days After the Second Vaccination;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each vaccination or Until Resolution;Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination or Until Resolution;Number of Participants with Unsolicited AEs;Serological Response to Vaccination as Measured by ELISA 14 Days After the Second Vaccination;Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After the First Vaccination

March 11, 2021, 12:31 a.m. usa

Number of Participants with Antibody Geometric Mean Concentration (GMC) 28 Days After First Vaccination;Number of Participants with Antibody GMC 28 Days After Second Vaccination;Number of Participants with MAAEs leading to Discontinuation;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Solicited Local Adverse Events (AEs);Number of Participants with Solicited Systemic AEs;Number of Participants with Unsolicited AEs;Serological Response to Vaccination as Measured by ELISA 28 Days After Second Vaccination;Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination

Number of Participants with Antibody Geometric Mean Concentration (GMC) 28 Days After First Vaccination;Number of Participants with Antibody GMC 28 Days After Second Vaccination;Number of Participants with MAAEs leading to Discontinuation;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Solicited Local Adverse Events (AEs);Number of Participants with Solicited Systemic AEs;Number of Participants with Unsolicited AEs;Serological Response to Vaccination as Measured by ELISA 28 Days After Second Vaccination;Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination

Feb. 23, 2021, 12:31 a.m. usa

Groups 1-10: Number of Participants with Antibody Geometric Mean Concentration (GMC) 28 Days After First Vaccination;Groups 1-10: Number of Participants with MAAEs leading to Discontinuation;Groups 1-10: Number of Participants with Medically-attended Adverse Events (MAAEs);Groups 1-10: Number of Participants with Serious Adverse Events (SAEs);Groups 1-10: Number of Participants with Solicited Local Adverse Events (AEs);Groups 1-10: Number of Participants with Solicited Systemic AEs;Groups 1-10: Number of Participants with Unsolicited AEs;Groups 1-10: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination;Groups 8-10: Number of Participants with Antibody GMC 28 Days After Second Vaccination;Groups 8-10: Serological Response to Vaccination as Measured by ELISA 28 Days After Second Vaccination

Groups 1-10: Number of Participants with Antibody Geometric Mean Concentration (GMC) 28 Days After First Vaccination;Groups 1-10: Number of Participants with MAAEs leading to Discontinuation;Groups 1-10: Number of Participants with Medically-attended Adverse Events (MAAEs);Groups 1-10: Number of Participants with Serious Adverse Events (SAEs);Groups 1-10: Number of Participants with Solicited Local Adverse Events (AEs);Groups 1-10: Number of Participants with Solicited Systemic AEs;Groups 1-10: Number of Participants with Unsolicited AEs;Groups 1-10: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination;Groups 8-10: Number of Participants with Antibody GMC 28 Days After Second Vaccination;Groups 8-10: Serological Response to Vaccination as Measured by ELISA 28 Days After Second Vaccination