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

inclusion criteria: 1. adults ≥ 18 years of age at the time of signing the informed consent 2. overtly healthy as determined by medical evaluation, or - medically stable such that, according to the judgment of the investigator, hospitalisation within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. o a stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment 3. able to understand and comply with study requirements/procedures based on the assessment of the investigator 4. reproduction: female participants 1. women of childbearing potential must: * have a negative pregnancy test on the day of screening and on day 1 * use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study vaccine. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. 2. women are considered of childbearing potential unless they meet either of the following criteria: * surgically sterilised (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or * postmenopausal 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol.

inclusion criteria: 1. adults ≥ 18 years of age at the time of signing the informed consent 2. overtly healthy as determined by medical evaluation, or - medically stable such that, according to the judgment of the investigator, hospitalisation within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. o a stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment 3. able to understand and comply with study requirements/procedures based on the assessment of the investigator 4. reproduction: female participants 1. women of childbearing potential must: * have a negative pregnancy test on the day of screening and on day 1 * use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study vaccine. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. 2. women are considered of childbearing potential unless they meet either of the following criteria: * surgically sterilised (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or * postmenopausal 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol.

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

inclusion criteria: adults ≥ 18 years of age at the time of signing the informed consent overtly healthy as determined by medical evaluation, or - medically stable such that, according to the judgment of the investigator, hospitalisation within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. o a stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment able to understand and comply with study requirements/procedures based on the assessment of the investigator reproduction: female participants women of childbearing potential must: have a negative pregnancy test on the day of screening and on day 1 use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study vaccine. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. women are considered of childbearing potential unless they meet either of the following criteria: surgically sterilised (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or postmenopausal 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol.

inclusion criteria: adults ≥ 18 years of age at the time of signing the informed consent overtly healthy as determined by medical evaluation, or - medically stable such that, according to the judgment of the investigator, hospitalisation within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. o a stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment able to understand and comply with study requirements/procedures based on the assessment of the investigator reproduction: female participants women of childbearing potential must: have a negative pregnancy test on the day of screening and on day 1 use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study vaccine. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. women are considered of childbearing potential unless they meet either of the following criteria: surgically sterilised (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or postmenopausal 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol.

Aug. 23, 2021, 7 p.m. usa

inclusion criteria: 1. adults ≥ 18 years of age at the time of signing the informed consent 2. overtly healthy as determined by medical evaluation, or - medically stable such that, according to the judgment of the investigator, hospitalisation within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. o a stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment 3. able to understand and comply with study requirements/procedures based on the assessment of the investigator 4. reproduction: female participants 1. women of childbearing potential must: - have a negative pregnancy test on the day of screening and on day 1 - use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study vaccine. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. 2. women are considered of childbearing potential unless they meet either of the following criteria: - surgically sterilised (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or - postmenopausal 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol.

inclusion criteria: 1. adults ≥ 18 years of age at the time of signing the informed consent 2. overtly healthy as determined by medical evaluation, or - medically stable such that, according to the judgment of the investigator, hospitalisation within the study period is not anticipated and the participant appears likely to be able to remain in follow-up through the end of protocol-specified follow-up. o a stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment 3. able to understand and comply with study requirements/procedures based on the assessment of the investigator 4. reproduction: female participants 1. women of childbearing potential must: - have a negative pregnancy test on the day of screening and on day 1 - use one highly effective form of birth control for at least 28 days prior to day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of the second dose of study vaccine. a highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. periodic abstinence, the rhythm method, and withdrawal are not acceptable methods of contraception. 2. women are considered of childbearing potential unless they meet either of the following criteria: - surgically sterilised (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or - postmenopausal 6. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol.

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

inclusion criteria: 1. adults ≥ 18 years of age at the time of signing the informed consent 2. healthy or medically stable 3. reproduction: female participants of childbearing potential should use appropriate contraception through 60 days following administration of the second dose

inclusion criteria: 1. adults ≥ 18 years of age at the time of signing the informed consent 2. healthy or medically stable 3. reproduction: female participants of childbearing potential should use appropriate contraception through 60 days following administration of the second dose

Dec. 26, 2020, 12:31 a.m. usa

inclusion criteria: 1. adults ≥ 18 years of age at the time of signing the informed consent 2. healthy or medically stable 3. reproduction: sexually active male participants should use a condom and female participants of childbearing potential should use appropriate contraception through 60 days following administration of the second dose

inclusion criteria: 1. adults ≥ 18 years of age at the time of signing the informed consent 2. healthy or medically stable 3. reproduction: sexually active male participants should use a condom and female participants of childbearing potential should use appropriate contraception through 60 days following administration of the second dose