Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: signed and dated informed consent obtained before undergoing any study-specific procedure healthy male or female aged ≥18 and ≤ 65 years body mass index >18.5 and ≤30 kg/m2 vital signs within the following values or ranges: body temperature ≤ 37,5 °c pulse frequency ≥51 and ≤100 beats per minute diastolic bp ≥60 mmhg, ≤ 90 mmhg systolic bp ≥ 90 mmhg, ≤ 140 mmhg respiratory rate ≥ 12 breaths per minute, ≤ 16 breaths per minute ecg at screening normal or with no clinically significant findings (pre-excitation syndromes, e.g., wolff-parkinson-white syndrome are absolute exclusion criteria) laboratory examinations within normal reference range or with no clinically significant abnormalities absence of any respiratory and flu-like symptoms non-pregnant women of childbearing potential, willing to practice a highly effective method of contraception from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal for sexually active men with a female partner of childbearing potential, willingness to use a condom and to refrain from donating sperm from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal agreement to refrain from blood donation during the course of the study able and willing to comply with all study procedures.

inclusion criteria: signed and dated informed consent obtained before undergoing any study-specific procedure healthy male or female aged ≥18 and ≤ 65 years body mass index >18.5 and ≤30 kg/m2 vital signs within the following values or ranges: body temperature ≤ 37,5 °c pulse frequency ≥51 and ≤100 beats per minute diastolic bp ≥60 mmhg, ≤ 90 mmhg systolic bp ≥ 90 mmhg, ≤ 140 mmhg respiratory rate ≥ 12 breaths per minute, ≤ 16 breaths per minute ecg at screening normal or with no clinically significant findings (pre-excitation syndromes, e.g., wolff-parkinson-white syndrome are absolute exclusion criteria) laboratory examinations within normal reference range or with no clinically significant abnormalities absence of any respiratory and flu-like symptoms non-pregnant women of childbearing potential, willing to practice a highly effective method of contraception from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal for sexually active men with a female partner of childbearing potential, willingness to use a condom and to refrain from donating sperm from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal agreement to refrain from blood donation during the course of the study able and willing to comply with all study procedures.

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

inclusion criteria: 1. signed and dated informed consent obtained before undergoing any study-specific procedure 2. healthy male or female aged ≥18 and ≤ 65 years 3. body mass index >18.5 and ≤30 kg/m2 4. vital signs within the following values or ranges: 1. body temperature ≤ 37,5 °c 2. pulse frequency ≥51 and ≤100 beats per minute 3. diastolic bp ≥60 mmhg, ≤ 90 mmhg 4. systolic bp ≥ 90 mmhg, ≤ 140 mmhg 5. respiratory rate ≥ 12 breaths per minute, ≤ 16 breaths per minute 5. ecg at screening normal or with no clinically significant findings (pre-excitation syndromes, e.g., wolff-parkinson-white syndrome are absolute exclusion criteria) 6. laboratory examinations within normal reference range or with no clinically significant abnormalities 7. absence of any respiratory and flu-like symptoms 8. non-pregnant women of childbearing potential, willing to practice a highly effective method of contraception from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal 9. for sexually active men with a female partner of childbearing potential, willingness to use a condom and to refrain from donating sperm from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal 10. agreement to refrain from blood donation during the course of the study 11. able and willing to comply with all study procedures.

inclusion criteria: 1. signed and dated informed consent obtained before undergoing any study-specific procedure 2. healthy male or female aged ≥18 and ≤ 65 years 3. body mass index >18.5 and ≤30 kg/m2 4. vital signs within the following values or ranges: 1. body temperature ≤ 37,5 °c 2. pulse frequency ≥51 and ≤100 beats per minute 3. diastolic bp ≥60 mmhg, ≤ 90 mmhg 4. systolic bp ≥ 90 mmhg, ≤ 140 mmhg 5. respiratory rate ≥ 12 breaths per minute, ≤ 16 breaths per minute 5. ecg at screening normal or with no clinically significant findings (pre-excitation syndromes, e.g., wolff-parkinson-white syndrome are absolute exclusion criteria) 6. laboratory examinations within normal reference range or with no clinically significant abnormalities 7. absence of any respiratory and flu-like symptoms 8. non-pregnant women of childbearing potential, willing to practice a highly effective method of contraception from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal 9. for sexually active men with a female partner of childbearing potential, willingness to use a condom and to refrain from donating sperm from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal 10. agreement to refrain from blood donation during the course of the study 11. able and willing to comply with all study procedures.