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

inclusion criteria for all participants: * healthy male and female participants aged 18 to 60 years inclusive. healthy participant is defined as an individual who is in good general health, not having any mental or physical disorder requiring regular or frequent medication. * expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. * physical examination and laboratory results without clinically significant findings according to the investigator's assessment. * body mass index (bmi) ≥18.0 and ≤30.0kg/m\^2 (≥18.0 and ≤32.0kg/m2 for participants with sars-cov-2 positive serology). * females: at the time of enrollment, negative human chorionic gonadotropin (hcg) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. on day 1 (pre-vaccination): negative urine pregnancy test (hcg), (only required if the serum pregnancy test was performed more than 3 days before). * females of childbearing potential must use highly effective methods of birth control from 1 month before the first administration of the trial vaccine until 3 months following the last administration. the following methods of birth control are considered highly effective when used consistently and correctly: * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); * progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); * intrauterine devices (iuds); * intrauterine hormone-releasing systems (iuss); * bilateral tubal occlusion; * vasectomized partner; * sexual abstinence (periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable).

inclusion criteria for all participants: * healthy male and female participants aged 18 to 60 years inclusive. healthy participant is defined as an individual who is in good general health, not having any mental or physical disorder requiring regular or frequent medication. * expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. * physical examination and laboratory results without clinically significant findings according to the investigator's assessment. * body mass index (bmi) ≥18.0 and ≤30.0kg/m\^2 (≥18.0 and ≤32.0kg/m2 for participants with sars-cov-2 positive serology). * females: at the time of enrollment, negative human chorionic gonadotropin (hcg) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. on day 1 (pre-vaccination): negative urine pregnancy test (hcg), (only required if the serum pregnancy test was performed more than 3 days before). * females of childbearing potential must use highly effective methods of birth control from 1 month before the first administration of the trial vaccine until 3 months following the last administration. the following methods of birth control are considered highly effective when used consistently and correctly: * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); * progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); * intrauterine devices (iuds); * intrauterine hormone-releasing systems (iuss); * bilateral tubal occlusion; * vasectomized partner; * sexual abstinence (periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable).

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

inclusion criteria for all participants: - healthy male and female participants aged 18 to 60 years inclusive. healthy participant is defined as an individual who is in good general health, not having any mental or physical disorder requiring regular or frequent medication. - expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. - physical examination and laboratory results without clinically significant findings according to the investigator's assessment. - body mass index (bmi) ≥18.0 and ≤30.0kg/m^2 (≥18.0 and ≤32.0kg/m2 for subjects with sars-cov-2 positive serology). - females: at the time of enrollment, negative human chorionic gonadotropin (hcg) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. on day 1 (pre-vaccination): negative urine pregnancy test (hcg), (only required if the serum pregnancy test was performed more than 3 days before). - females of childbearing potential must use highly effective methods of birth control from 1 month before the first administration of the trial vaccine until 3 months following the last administration. the following methods of birth control are considered highly effective when used consistently and correctly: - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); - progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); - intrauterine devices (iuds); - intrauterine hormone-releasing systems (iuss); - bilateral tubal occlusion; - vasectomized partner; - sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable).

inclusion criteria for all participants: - healthy male and female participants aged 18 to 60 years inclusive. healthy participant is defined as an individual who is in good general health, not having any mental or physical disorder requiring regular or frequent medication. - expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. - physical examination and laboratory results without clinically significant findings according to the investigator's assessment. - body mass index (bmi) ≥18.0 and ≤30.0kg/m^2 (≥18.0 and ≤32.0kg/m2 for subjects with sars-cov-2 positive serology). - females: at the time of enrollment, negative human chorionic gonadotropin (hcg) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. on day 1 (pre-vaccination): negative urine pregnancy test (hcg), (only required if the serum pregnancy test was performed more than 3 days before). - females of childbearing potential must use highly effective methods of birth control from 1 month before the first administration of the trial vaccine until 3 months following the last administration. the following methods of birth control are considered highly effective when used consistently and correctly: - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); - progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); - intrauterine devices (iuds); - intrauterine hormone-releasing systems (iuss); - bilateral tubal occlusion; - vasectomized partner; - sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable).