Created at Source Raw Value Validated value
May 26, 2024, midnight usa

Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1;Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2;Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1;Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2;Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination;Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1;Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2;Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1;Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2;Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1;Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2;Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination;Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1;Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2;Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen;Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination;Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen;Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen;Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs);Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs);Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination;Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen;Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen;Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs);Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs);Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen

Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1;Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2;Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1;Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2;Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination;Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1;Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2;Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1;Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2;Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1;Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2;Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination;Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1;Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2;Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen;Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination;Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen;Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen;Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs);Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs);Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination;Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen;Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination;Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen;Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen;Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs);Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs);Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen;Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen

July 1, 2022, 11 p.m. usa

Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the Second Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination;Cohorts 1 and 3: Number of Participants with Adverse Events of Special Interest (AESIs) from the First Vaccination until 2 Years after the Second Vaccination;Cohorts 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 2 Years after the Second Vaccination;Number of Participants with AESIs from ad hoc Booster Vaccination Until the end of the Study;Number of Participants with SAEs from ad hoc Booster Vaccination Until the end of the Study;Number of Participants with Solicited Local AEs for 7 Days after ad hoc Booster Vaccination;Number of Participants with Solicited Systemic AEs for 7 Days after ad hoc Booster Vaccination;Number of Participants with Unsolicited AEs for 28 Days after ad hoc Booster Vaccination

Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the Second Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination;Cohorts 1 and 3: Number of Participants with Adverse Events of Special Interest (AESIs) from the First Vaccination until 2 Years after the Second Vaccination;Cohorts 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 2 Years after the Second Vaccination;Number of Participants with AESIs from ad hoc Booster Vaccination Until the end of the Study;Number of Participants with SAEs from ad hoc Booster Vaccination Until the end of the Study;Number of Participants with Solicited Local AEs for 7 Days after ad hoc Booster Vaccination;Number of Participants with Solicited Systemic AEs for 7 Days after ad hoc Booster Vaccination;Number of Participants with Unsolicited AEs for 28 Days after ad hoc Booster Vaccination

June 9, 2022, 4 p.m. usa

None

Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination [ Time Frame: Day 8 (7 Days after first vaccination on Day 1) ] Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after first vaccination. Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination [ Time Frame: Day 64 (7 Days after second vaccination on Day 57) ] Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after second vaccination. Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination [ Time Frame: Day 8 (7 Days after first vaccination on Day 1) ] Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after first vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia. Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination [ Time Frame: Day 64 (7 Days after second vaccination on Day 57) ] Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after second vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia. Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination [ Time Frame: Day 29 (28 Days after first vaccination on Day1) ] Number of participants with unsolicited AEs for 28 days after first vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned. Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination [ Time Frame: Day 85 (28 Days after second vaccination) ] Number of participants with unsolicited AEs for 28 days after second vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned. Cohorts 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 2 Years after the Second Vaccination [ Time Frame: Day 1 (vaccination 1) up to 2 years after second vaccination (up to Day 787) ] SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: 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. Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination [ Time Frame: Day 1 (vaccination 1) up to 6 Months ] SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: 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. Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the Second Vaccination [ Time Frame: Day 1 (vaccination 1) up to 6 months after second vaccination (Day 239) ] SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: 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. Cohorts 1 and 3: Number of Participants with Adverse Events of Special Interest (AESIs) from the First Vaccination until 2 Years after the Second Vaccination [ Time Frame: Day 1 (vaccination 1) up to 2 year after second vaccination (up to Day 787) ] Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI. Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the First Vaccination [ Time Frame: Day 1 (vaccination 1) up to 6 Months ] Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI. Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the Second Vaccination [ Time Frame: Day 1 (vaccination 1) up to 6 months after second vaccination (Day 239) ] Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI. Number of Participants with Solicited Local AEs for 7 Days after ad hoc Booster Vaccination [ Time Frame: Up to 7 days after ad hoc booster vaccination ] Solicited local AEs are pre-defined local (at the injection site) adverse events for which participants are specifically questioned and which are noted by participants in their diary for 7 days after ad hoc vaccination. Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. Number of Participants with Solicited Systemic AEs for 7 Days after ad hoc Booster Vaccination [ Time Frame: Up to 7 days after ad hoc booster vaccination ] Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after ad hoc booster vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia. Number of Participants with Unsolicited AEs for 28 Days after ad hoc Booster Vaccination [ Time Frame: Up to 28 days after ad hoc booster vaccination ] Number of participants with unsolicited AEs for 28 days after ad hoc booster vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned. Number of Participants with SAEs from ad hoc Booster Vaccination Until the end of the Study [ Time Frame: from ad hoc booster vaccination (greater or equal to [>=] 6 months after last Covid-19 vaccination [within 120 days]) to end of study (up to 38 months) ] SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: 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 AESIs from ad hoc Booster Vaccination Until the end of the Study [ Time Frame: from ad hoc booster vaccination (>= 6 months after last Covid-19 vaccination [within 120 days]) to end of study (up to 38 months) ] Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.

Nov. 19, 2021, 7:30 p.m. usa

Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the Second Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination;Cohorts 1 and 3: Number of Participants with Adverse Events of Special Interest (AESIs) from the First Vaccination until 2 Years after the Second Vaccination;Cohorts 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 2 Years after the Second Vaccination;Number of Participants with AESIs from ad hoc Booster Vaccination Until the end of the Study;Number of Participants with SAEs from ad hoc Booster Vaccination Until the end of the Study;Number of Participants with Solicited Local AEs for 7 Days after ad hoc Booster Vaccination;Number of Participants with Solicited Systemic AEs for 7 Days after ad hoc Booster Vaccination;Number of Participants with Unsolicited AEs for 28 Days after ad hoc Booster Vaccination

Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the Second Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination;Cohorts 1 and 3: Number of Participants with Adverse Events of Special Interest (AESIs) from the First Vaccination until 2 Years after the Second Vaccination;Cohorts 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 2 Years after the Second Vaccination;Number of Participants with AESIs from ad hoc Booster Vaccination Until the end of the Study;Number of Participants with SAEs from ad hoc Booster Vaccination Until the end of the Study;Number of Participants with Solicited Local AEs for 7 Days after ad hoc Booster Vaccination;Number of Participants with Solicited Systemic AEs for 7 Days after ad hoc Booster Vaccination;Number of Participants with Unsolicited AEs for 28 Days after ad hoc Booster Vaccination

Aug. 31, 2021, 8:30 p.m. usa

Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the Second Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination;Cohorts 1 and 3: Number of Participants with Adverse Events of Special Interest (AESIs) from the First Vaccination until 2 Years after the Second Vaccination;Cohorts 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 2 Years after the Second Vaccination

Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the Second Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination;Cohorts 1 and 3: Number of Participants with Adverse Events of Special Interest (AESIs) from the First Vaccination until 2 Years after the Second Vaccination;Cohorts 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 2 Years after the Second Vaccination

July 14, 2021, 6 a.m. usa

Cohort 1 and 3: Number of Participants with Adverse Events of Special Interest (AESIs) from the First Vaccination until 1 Year after the Second Vaccination;Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the Second Vaccination;Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the Second Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination

Cohort 1 and 3: Number of Participants with Adverse Events of Special Interest (AESIs) from the First Vaccination until 1 Year after the Second Vaccination;Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the Second Vaccination;Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the Second Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination

Oct. 26, 2020, 11:31 p.m. usa

Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination;Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the Second Vaccination

Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination;Cohort 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 1 Year after the Second Vaccination