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

inclusion criteria: 1. caucasian race, 18 to 64 years of age male or female (both inclusive), 2. accepting not to participate in another covid-19 vaccine study until the end of the study, 3. voluntarily gives written informed consent prior to any study-related procedures. 4. has a body mass index (bmi) of 18.5-32.0 kg/m2-both inclusive, 5. has a normal/acceptable ecg result 6. for female volunteers of childbearing potential, a negative serum pregnancy test within seven days before vaccination: * females of childbearing potential are defined as fertile following menarche and until becoming postmenopausal or permanently sterile. (postmenopausal is defined as absence of vaginal bleeding or spotting for at least one year. permanently sterile is defined as having had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.) 7. for female volunteers of childbearing potential, volunteers who do not plan to get a child in the next one year; a willingness to use highly effective\* contraceptive measures adequate to prevent a new pregnancy for the duration of the study, including for at least 12 months after receiving the first dose of study vaccination. for women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended. \* highly effective methods of birth control are defined as those that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (e.g. implants, injectables, oral contraceptives, some intrauterine devices, bilateral tubal occlusion, true sexual abstinence in line with the preferred and usual lifestyle of the volunteer, or vasectomized partner). 8. for sexually active males, a willingness to use contraceptive measures, e.g. a condom, for the duration of the study, including for at least three months after receiving the last dose of study vaccination. in addition, males must agree not to donate sperm over the same study period and for at least three months after receiving the last dose of study vaccination. 9. anti-sars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. 10. physical examination, if indicated only (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable.

inclusion criteria: 1. caucasian race, 18 to 64 years of age male or female (both inclusive), 2. accepting not to participate in another covid-19 vaccine study until the end of the study, 3. voluntarily gives written informed consent prior to any study-related procedures. 4. has a body mass index (bmi) of 18.5-32.0 kg/m2-both inclusive, 5. has a normal/acceptable ecg result 6. for female volunteers of childbearing potential, a negative serum pregnancy test within seven days before vaccination: * females of childbearing potential are defined as fertile following menarche and until becoming postmenopausal or permanently sterile. (postmenopausal is defined as absence of vaginal bleeding or spotting for at least one year. permanently sterile is defined as having had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.) 7. for female volunteers of childbearing potential, volunteers who do not plan to get a child in the next one year; a willingness to use highly effective\* contraceptive measures adequate to prevent a new pregnancy for the duration of the study, including for at least 12 months after receiving the first dose of study vaccination. for women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended. \* highly effective methods of birth control are defined as those that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (e.g. implants, injectables, oral contraceptives, some intrauterine devices, bilateral tubal occlusion, true sexual abstinence in line with the preferred and usual lifestyle of the volunteer, or vasectomized partner). 8. for sexually active males, a willingness to use contraceptive measures, e.g. a condom, for the duration of the study, including for at least three months after receiving the last dose of study vaccination. in addition, males must agree not to donate sperm over the same study period and for at least three months after receiving the last dose of study vaccination. 9. anti-sars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. 10. physical examination, if indicated only (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable.

Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: caucasian race, 18 to 64 years of age male or female (both inclusive), accepting not to participate in another covid-19 vaccine study until the end of the study, voluntarily gives written informed consent prior to any study-related procedures. has a body mass index (bmi) of 18.5-32.0 kg/m2-both inclusive, has a normal/acceptable ecg result for female volunteers of childbearing potential, a negative serum pregnancy test within seven days before vaccination: females of childbearing potential are defined as fertile following menarche and until becoming postmenopausal or permanently sterile. (postmenopausal is defined as absence of vaginal bleeding or spotting for at least one year. permanently sterile is defined as having had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.) for female volunteers of childbearing potential, volunteers who do not plan to get a child in the next one year; a willingness to use highly effective* contraceptive measures adequate to prevent a new pregnancy for the duration of the study, including for at least 12 months after receiving the first dose of study vaccination. for women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended. * highly effective methods of birth control are defined as those that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (e.g. implants, injectables, oral contraceptives, some intrauterine devices, bilateral tubal occlusion, true sexual abstinence in line with the preferred and usual lifestyle of the volunteer, or vasectomized partner). for sexually active males, a willingness to use contraceptive measures, e.g. a condom, for the duration of the study, including for at least three months after receiving the last dose of study vaccination. in addition, males must agree not to donate sperm over the same study period and for at least three months after receiving the last dose of study vaccination. anti-sars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. physical examination, if indicated only (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable.

inclusion criteria: caucasian race, 18 to 64 years of age male or female (both inclusive), accepting not to participate in another covid-19 vaccine study until the end of the study, voluntarily gives written informed consent prior to any study-related procedures. has a body mass index (bmi) of 18.5-32.0 kg/m2-both inclusive, has a normal/acceptable ecg result for female volunteers of childbearing potential, a negative serum pregnancy test within seven days before vaccination: females of childbearing potential are defined as fertile following menarche and until becoming postmenopausal or permanently sterile. (postmenopausal is defined as absence of vaginal bleeding or spotting for at least one year. permanently sterile is defined as having had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.) for female volunteers of childbearing potential, volunteers who do not plan to get a child in the next one year; a willingness to use highly effective* contraceptive measures adequate to prevent a new pregnancy for the duration of the study, including for at least 12 months after receiving the first dose of study vaccination. for women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended. * highly effective methods of birth control are defined as those that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (e.g. implants, injectables, oral contraceptives, some intrauterine devices, bilateral tubal occlusion, true sexual abstinence in line with the preferred and usual lifestyle of the volunteer, or vasectomized partner). for sexually active males, a willingness to use contraceptive measures, e.g. a condom, for the duration of the study, including for at least three months after receiving the last dose of study vaccination. in addition, males must agree not to donate sperm over the same study period and for at least three months after receiving the last dose of study vaccination. anti-sars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. physical examination, if indicated only (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable.

Sept. 7, 2021, 2 a.m. usa

inclusion criteria: 1. caucasian race, 18 to 64 years of age male or female (both inclusive), 2. accepting not to participate in another covid-19 vaccine study until the end of the study, 3. voluntarily gives written informed consent prior to any study-related procedures. 4. has a body mass index (bmi) of 18.5-32.0 kg/m2-both inclusive, 5. has a normal/acceptable ecg result 6. for female volunteers of childbearing potential, a negative serum pregnancy test within seven days before vaccination: - females of childbearing potential are defined as fertile following menarche and until becoming postmenopausal or permanently sterile. (postmenopausal is defined as absence of vaginal bleeding or spotting for at least one year. permanently sterile is defined as having had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.) 7. for female volunteers of childbearing potential, volunteers who do not plan to get a child in the next one year; a willingness to use highly effective* contraceptive measures adequate to prevent a new pregnancy for the duration of the study, including for at least 12 months after receiving the first dose of study vaccination. for women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended. * highly effective methods of birth control are defined as those that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (e.g. implants, injectables, oral contraceptives, some intrauterine devices, bilateral tubal occlusion, true sexual abstinence in line with the preferred and usual lifestyle of the volunteer, or vasectomized partner). 8. for sexually active males, a willingness to use contraceptive measures, e.g. a condom, for the duration of the study, including for at least three months after receiving the last dose of study vaccination. in addition, males must agree not to donate sperm over the same study period and for at least three months after receiving the last dose of study vaccination. 9. anti-sars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. 10. physical examination, if indicated only (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable.

inclusion criteria: 1. caucasian race, 18 to 64 years of age male or female (both inclusive), 2. accepting not to participate in another covid-19 vaccine study until the end of the study, 3. voluntarily gives written informed consent prior to any study-related procedures. 4. has a body mass index (bmi) of 18.5-32.0 kg/m2-both inclusive, 5. has a normal/acceptable ecg result 6. for female volunteers of childbearing potential, a negative serum pregnancy test within seven days before vaccination: - females of childbearing potential are defined as fertile following menarche and until becoming postmenopausal or permanently sterile. (postmenopausal is defined as absence of vaginal bleeding or spotting for at least one year. permanently sterile is defined as having had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.) 7. for female volunteers of childbearing potential, volunteers who do not plan to get a child in the next one year; a willingness to use highly effective* contraceptive measures adequate to prevent a new pregnancy for the duration of the study, including for at least 12 months after receiving the first dose of study vaccination. for women with reproductive potential who use a hormonal method of contraception, concurrent use of a second (barrier) method is recommended. * highly effective methods of birth control are defined as those that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (e.g. implants, injectables, oral contraceptives, some intrauterine devices, bilateral tubal occlusion, true sexual abstinence in line with the preferred and usual lifestyle of the volunteer, or vasectomized partner). 8. for sexually active males, a willingness to use contraceptive measures, e.g. a condom, for the duration of the study, including for at least three months after receiving the last dose of study vaccination. in addition, males must agree not to donate sperm over the same study period and for at least three months after receiving the last dose of study vaccination. 9. anti-sars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. 10. physical examination, if indicated only (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable.