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

inclusion criteria: * healthy caucasian origin * accepting not to participate in another covid-19 vaccine study until the end of the study * volunteers who do not plan to get a child in the next one year; the volunteer and the partner should use a reliable form of contraception (abstinence, condom, birth control implant, birth control pills used or iud used by the partner) during the study for at least 1 year * female participants of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination or agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination. * male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination * participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination * the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); * life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable * body temperature, pulse rate, blood pressure and respiratory rate should be normal/acceptable. * laboratory examination (blood/serum examination: sodium, potassium, calcium, total protein, albumin, glucose, creatinine, bun, total bilirubin, ast, alt, ggt, alp, haemoglobin, haematocrit, erythrocytes, ieukocytes, platelet count; hbsag, hiv-ab, hcv-ab should be normal/acceptable. * antisars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. * body weight in relation to height and age accepted bmi range 18.5 and 32 kg/m2 - both inclusive

inclusion criteria: * healthy caucasian origin * accepting not to participate in another covid-19 vaccine study until the end of the study * volunteers who do not plan to get a child in the next one year; the volunteer and the partner should use a reliable form of contraception (abstinence, condom, birth control implant, birth control pills used or iud used by the partner) during the study for at least 1 year * female participants of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination or agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination. * male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination * participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination * the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); * life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable * body temperature, pulse rate, blood pressure and respiratory rate should be normal/acceptable. * laboratory examination (blood/serum examination: sodium, potassium, calcium, total protein, albumin, glucose, creatinine, bun, total bilirubin, ast, alt, ggt, alp, haemoglobin, haematocrit, erythrocytes, ieukocytes, platelet count; hbsag, hiv-ab, hcv-ab should be normal/acceptable. * antisars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. * body weight in relation to height and age accepted bmi range 18.5 and 32 kg/m2 - both inclusive

April 6, 2021, 12:31 a.m. usa

inclusion criteria: - healthy caucasian origin - accepting not to participate in another covid-19 vaccine study until the end of the study - volunteers who do not plan to get a child in the next one year; the volunteer and the partner should use a reliable form of contraception (abstinence, condom, birth control implant, birth control pills used or iud used by the partner) during the study for at least 1 year - female participants of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination or agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination. - male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination - participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination - the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); - life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable - body temperature, pulse rate, blood pressure and respiratory rate should be normal/acceptable. - laboratory examination (blood/serum examination: sodium, potassium, calcium, total protein, albumin, glucose, creatinine, bun, total bilirubin, ast, alt, ggt, alp, haemoglobin, haematocrit, erythrocytes, ieukocytes, platelet count; hbsag, hiv-ab, hcv-ab should be normal/acceptable. - antisars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. - body weight in relation to height and age accepted bmi range 18.5 and 32 kg/m2 - both inclusive

inclusion criteria: - healthy caucasian origin - accepting not to participate in another covid-19 vaccine study until the end of the study - volunteers who do not plan to get a child in the next one year; the volunteer and the partner should use a reliable form of contraception (abstinence, condom, birth control implant, birth control pills used or iud used by the partner) during the study for at least 1 year - female participants of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination or agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination. - male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination - participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination - the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); - life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable - body temperature, pulse rate, blood pressure and respiratory rate should be normal/acceptable. - laboratory examination (blood/serum examination: sodium, potassium, calcium, total protein, albumin, glucose, creatinine, bun, total bilirubin, ast, alt, ggt, alp, haemoglobin, haematocrit, erythrocytes, ieukocytes, platelet count; hbsag, hiv-ab, hcv-ab should be normal/acceptable. - antisars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. - body weight in relation to height and age accepted bmi range 18.5 and 32 kg/m2 - both inclusive