Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: * men and women aged 18 years and older * written informed consent of the volunteer to participate in the clinical trial (in paper or electronic form) * bmi within the range of 18.5 ≤ bwi ≤ 30 kg/m2 with the body weight of not less than 55 kg for men, not less than 45 kg for women and not more than 100 kg for volunteers of both sexes * absence of clinically significant (according to the investigator) deviations from the reference values of clinical, laboratory and instrumental methods of examination at screening * hemodynamic and other vital signs are within normal limits (reference intervals are 60-90 beats/min at rest for hr, up to 22 per minute for rr, body temperature from 35.5 to 36.9 °c; systolic blood pressure (sbp) is considered normal in the range of 100-139 mmhg, diastolic blood pressure (dbp) - in the range of 60-89 mmhg) * volunteers able to fulfill requirements of the protocol (i.e., fill in the electronic patient's diary, come to follow-up visits) * abstinence from alcohol from the start of screening until completion of visit 7 procedures (day 42 ± 2) - for stage 2b * for fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination * for fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years * throughout the study, the opportunity to use own smartphone with the ability to fill in the electronic patient's diary

inclusion criteria: * men and women aged 18 years and older * written informed consent of the volunteer to participate in the clinical trial (in paper or electronic form) * bmi within the range of 18.5 ≤ bwi ≤ 30 kg/m2 with the body weight of not less than 55 kg for men, not less than 45 kg for women and not more than 100 kg for volunteers of both sexes * absence of clinically significant (according to the investigator) deviations from the reference values of clinical, laboratory and instrumental methods of examination at screening * hemodynamic and other vital signs are within normal limits (reference intervals are 60-90 beats/min at rest for hr, up to 22 per minute for rr, body temperature from 35.5 to 36.9 °c; systolic blood pressure (sbp) is considered normal in the range of 100-139 mmhg, diastolic blood pressure (dbp) - in the range of 60-89 mmhg) * volunteers able to fulfill requirements of the protocol (i.e., fill in the electronic patient's diary, come to follow-up visits) * abstinence from alcohol from the start of screening until completion of visit 7 procedures (day 42 ± 2) - for stage 2b * for fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination * for fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years * throughout the study, the opportunity to use own smartphone with the ability to fill in the electronic patient's diary

Feb. 14, 2023, noon usa

inclusion criteria: men and women aged 18 years and older written informed consent of the volunteer to participate in the clinical trial (in paper or electronic form) bmi within the range of 18.5 ≤ bwi ≤ 30 kg/m2 with the body weight of not less than 55 kg for men, not less than 45 kg for women and not more than 100 kg for volunteers of both sexes absence of clinically significant (according to the investigator) deviations from the reference values of clinical, laboratory and instrumental methods of examination at screening hemodynamic and other vital signs are within normal limits (reference intervals are 60-90 beats/min at rest for hr, up to 22 per minute for rr, body temperature from 35.5 to 36.9 °c; systolic blood pressure (sbp) is considered normal in the range of 100-139 mmhg, diastolic blood pressure (dbp) - in the range of 60-89 mmhg) volunteers able to fulfill requirements of the protocol (i.e., fill in the electronic patient's diary, come to follow-up visits) abstinence from alcohol from the start of screening until completion of visit 7 procedures (day 42 ± 2) - for stage 2b for fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination for fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years throughout the study, the opportunity to use own smartphone with the ability to fill in the electronic patient's diary

inclusion criteria: men and women aged 18 years and older written informed consent of the volunteer to participate in the clinical trial (in paper or electronic form) bmi within the range of 18.5 ≤ bwi ≤ 30 kg/m2 with the body weight of not less than 55 kg for men, not less than 45 kg for women and not more than 100 kg for volunteers of both sexes absence of clinically significant (according to the investigator) deviations from the reference values of clinical, laboratory and instrumental methods of examination at screening hemodynamic and other vital signs are within normal limits (reference intervals are 60-90 beats/min at rest for hr, up to 22 per minute for rr, body temperature from 35.5 to 36.9 °c; systolic blood pressure (sbp) is considered normal in the range of 100-139 mmhg, diastolic blood pressure (dbp) - in the range of 60-89 mmhg) volunteers able to fulfill requirements of the protocol (i.e., fill in the electronic patient's diary, come to follow-up visits) abstinence from alcohol from the start of screening until completion of visit 7 procedures (day 42 ± 2) - for stage 2b for fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination for fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years throughout the study, the opportunity to use own smartphone with the ability to fill in the electronic patient's diary