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

inclusion criteria: 1. healthy male or non-pregnant female, ≥18 and ≤50 years of age, with bmi ≥18 and ≤ 34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females. 2. healthy as defined by: 1. the absence of clinically significant illness and surgery within 28 days prior to dosing. subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. inclusion of pre-dosing is at the discretion of the investigator, and the subject may have their scheduled dosing postponed until the condition resolves. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. 3. non-smokers or social smokers (defined as the equivalent or fewer than 10 cigarettes per week). ex-heavy smokers (heavy smoking is defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit or reduced their cigarette intake to the defined level of social smoking, for a period of at least 12 months. ex-moderate level smokers (i.e. \>10 per week but \<25 per day) may be admitted if they have quit or reduced their cigarette intake to the defined level of social smoking, for a period of at least 6 months. 4. all women of child bearing potential (wocbp) and men must refrain from sperm/egg donation and must be able and willing to use at least 1 highly effective method of contraception commencing at least 28 days prior to vaccine administration and for 3 months after vaccine administration. subjects in same sex relationships must be able and willing to refrain from sperm/egg donation for 3 months after vaccine administration. a female subject is considered to be a wocbp following menarche and until she is in a post-menopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). a follicle-stimulating hormone (fsh) test may be used to confirm a post-menopausal state. examples of acceptable methods of contraceptive methods (for female subjects and female partners of male subjects) to be used throughout the study include 1. use of hormonal contraceptives, started at at least 28 days prior to study treatment administration and must agree to use the same hormonal contraceptive throughout the study; 2. use of an intra-uterine contraceptive device, placed at at least 28 days prior to study treatment administration; 3. use of a diaphragm, started at least 28 days prior to study treatment administration; 4. use of condoms for male subjects whose partners are pregnant to ensure that the foetus is not exposed to the study vaccine; 5. sterile male partner (vasectomized since at least 6 months prior to study treatment administration) 6. true abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) from the time of enrollment and at for at least 28 days prior to study treatment administration and for at least the duration of the study. periodic abstinence and withdrawal are not acceptable methods. 5. must meet the following covid-19 vaccination status: 1. have completed a primary sars-cov-2 vaccination series with either the pfizer or moderna covid-19 vaccine, and 2. have received at least one booster dose of the pfizer or moderna sars-cov-2 vaccine at least 3 months prior to study entry. 6. wocbp must return a negative urine pregnancy test prior to receiving the study treatment. 7. male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from study treatment administration until at least 90 days after the last study treatment administration. 8. must be willing to refrain from blood (and plasma) donation throughout study participation. 9. must be able to attend all visits for the duration of the study and comply with all study procedures according to the study schedule.

inclusion criteria: 1. healthy male or non-pregnant female, ≥18 and ≤50 years of age, with bmi ≥18 and ≤ 34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females. 2. healthy as defined by: 1. the absence of clinically significant illness and surgery within 28 days prior to dosing. subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. inclusion of pre-dosing is at the discretion of the investigator, and the subject may have their scheduled dosing postponed until the condition resolves. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. 3. non-smokers or social smokers (defined as the equivalent or fewer than 10 cigarettes per week). ex-heavy smokers (heavy smoking is defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit or reduced their cigarette intake to the defined level of social smoking, for a period of at least 12 months. ex-moderate level smokers (i.e. \>10 per week but \<25 per day) may be admitted if they have quit or reduced their cigarette intake to the defined level of social smoking, for a period of at least 6 months. 4. all women of child bearing potential (wocbp) and men must refrain from sperm/egg donation and must be able and willing to use at least 1 highly effective method of contraception commencing at least 28 days prior to vaccine administration and for 3 months after vaccine administration. subjects in same sex relationships must be able and willing to refrain from sperm/egg donation for 3 months after vaccine administration. a female subject is considered to be a wocbp following menarche and until she is in a post-menopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). a follicle-stimulating hormone (fsh) test may be used to confirm a post-menopausal state. examples of acceptable methods of contraceptive methods (for female subjects and female partners of male subjects) to be used throughout the study include 1. use of hormonal contraceptives, started at at least 28 days prior to study treatment administration and must agree to use the same hormonal contraceptive throughout the study; 2. use of an intra-uterine contraceptive device, placed at at least 28 days prior to study treatment administration; 3. use of a diaphragm, started at least 28 days prior to study treatment administration; 4. use of condoms for male subjects whose partners are pregnant to ensure that the foetus is not exposed to the study vaccine; 5. sterile male partner (vasectomized since at least 6 months prior to study treatment administration) 6. true abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) from the time of enrollment and at for at least 28 days prior to study treatment administration and for at least the duration of the study. periodic abstinence and withdrawal are not acceptable methods. 5. must meet the following covid-19 vaccination status: 1. have completed a primary sars-cov-2 vaccination series with either the pfizer or moderna covid-19 vaccine, and 2. have received at least one booster dose of the pfizer or moderna sars-cov-2 vaccine at least 3 months prior to study entry. 6. wocbp must return a negative urine pregnancy test prior to receiving the study treatment. 7. male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from study treatment administration until at least 90 days after the last study treatment administration. 8. must be willing to refrain from blood (and plasma) donation throughout study participation. 9. must be able to attend all visits for the duration of the study and comply with all study procedures according to the study schedule.

March 21, 2023, 4 p.m. usa

inclusion criteria: healthy male or non-pregnant female, ≥18 and ≤50 years of age, with bmi ≥18 and ≤ 34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females. healthy as defined by: the absence of clinically significant illness and surgery within 28 days prior to dosing. subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. inclusion of pre-dosing is at the discretion of the investigator, and the subject may have their scheduled dosing postponed until the condition resolves. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. non-smokers or social smokers (defined as the equivalent or fewer than 10 cigarettes per week). ex-heavy smokers (heavy smoking is defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit or reduced their cigarette intake to the defined level of social smoking, for a period of at least 12 months. ex-moderate level smokers (i.e. >10 per week but <25 per day) may be admitted if they have quit or reduced their cigarette intake to the defined level of social smoking, for a period of at least 6 months. all women of child bearing potential (wocbp) and men must refrain from sperm/egg donation and must be able and willing to use at least 1 highly effective method of contraception commencing at least 28 days prior to vaccine administration and for 3 months after vaccine administration. subjects in same sex relationships must be able and willing to refrain from sperm/egg donation for 3 months after vaccine administration. a female subject is considered to be a wocbp following menarche and until she is in a post-menopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). a follicle-stimulating hormone (fsh) test may be used to confirm a post-menopausal state. examples of acceptable methods of contraceptive methods (for female subjects and female partners of male subjects) to be used throughout the study include use of hormonal contraceptives, started at at least 28 days prior to study treatment administration and must agree to use the same hormonal contraceptive throughout the study; use of an intra-uterine contraceptive device, placed at at least 28 days prior to study treatment administration; use of a diaphragm, started at least 28 days prior to study treatment administration; use of condoms for male subjects whose partners are pregnant to ensure that the foetus is not exposed to the study vaccine; sterile male partner (vasectomized since at least 6 months prior to study treatment administration) true abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) from the time of enrollment and at for at least 28 days prior to study treatment administration and for at least the duration of the study. periodic abstinence and withdrawal are not acceptable methods. must meet the following covid-19 vaccination status: have completed a primary sars-cov-2 vaccination series with either the pfizer or moderna covid-19 vaccine, and have received at least one booster dose of the pfizer or moderna sars-cov-2 vaccine at least 3 months prior to study entry. wocbp must return a negative urine pregnancy test prior to receiving the study treatment. male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from study treatment administration until at least 90 days after the last study treatment administration. must be willing to refrain from blood (and plasma) donation throughout study participation. must be able to attend all visits for the duration of the study and comply with all study procedures according to the study schedule.

inclusion criteria: healthy male or non-pregnant female, ≥18 and ≤50 years of age, with bmi ≥18 and ≤ 34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females. healthy as defined by: the absence of clinically significant illness and surgery within 28 days prior to dosing. subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. inclusion of pre-dosing is at the discretion of the investigator, and the subject may have their scheduled dosing postponed until the condition resolves. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. non-smokers or social smokers (defined as the equivalent or fewer than 10 cigarettes per week). ex-heavy smokers (heavy smoking is defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit or reduced their cigarette intake to the defined level of social smoking, for a period of at least 12 months. ex-moderate level smokers (i.e. >10 per week but <25 per day) may be admitted if they have quit or reduced their cigarette intake to the defined level of social smoking, for a period of at least 6 months. all women of child bearing potential (wocbp) and men must refrain from sperm/egg donation and must be able and willing to use at least 1 highly effective method of contraception commencing at least 28 days prior to vaccine administration and for 3 months after vaccine administration. subjects in same sex relationships must be able and willing to refrain from sperm/egg donation for 3 months after vaccine administration. a female subject is considered to be a wocbp following menarche and until she is in a post-menopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). a follicle-stimulating hormone (fsh) test may be used to confirm a post-menopausal state. examples of acceptable methods of contraceptive methods (for female subjects and female partners of male subjects) to be used throughout the study include use of hormonal contraceptives, started at at least 28 days prior to study treatment administration and must agree to use the same hormonal contraceptive throughout the study; use of an intra-uterine contraceptive device, placed at at least 28 days prior to study treatment administration; use of a diaphragm, started at least 28 days prior to study treatment administration; use of condoms for male subjects whose partners are pregnant to ensure that the foetus is not exposed to the study vaccine; sterile male partner (vasectomized since at least 6 months prior to study treatment administration) true abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) from the time of enrollment and at for at least 28 days prior to study treatment administration and for at least the duration of the study. periodic abstinence and withdrawal are not acceptable methods. must meet the following covid-19 vaccination status: have completed a primary sars-cov-2 vaccination series with either the pfizer or moderna covid-19 vaccine, and have received at least one booster dose of the pfizer or moderna sars-cov-2 vaccine at least 3 months prior to study entry. wocbp must return a negative urine pregnancy test prior to receiving the study treatment. male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from study treatment administration until at least 90 days after the last study treatment administration. must be willing to refrain from blood (and plasma) donation throughout study participation. must be able to attend all visits for the duration of the study and comply with all study procedures according to the study schedule.