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

inclusion criteria: 1. participants are: 1. overtly healthy as determined by medical examination, or 2. 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. (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.) 2. able to understand and comply with study requirements/procedures based on the assessment of the investigator. 3. female participants 1. women of childbearing potential must: * have a negative pregnancy test on the day of screening and day 1. * use of a 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 (see the table below). 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 sterilized (including bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or * postmenopausal * for women aged \< 50 years old, postmenopause is defined as having both: * a history ≥ 12 months amenorrhea prior to the first dosing, without an alternative cause, following cessation of exogenous sex hormone treatment and * a follicle-stimulating hormone level in post-menopausal range. (until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential.) * for women aged ≥ 50 years old, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex hormone treatment. 4. 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. participants are: 1. overtly healthy as determined by medical examination, or 2. 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. (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.) 2. able to understand and comply with study requirements/procedures based on the assessment of the investigator. 3. female participants 1. women of childbearing potential must: * have a negative pregnancy test on the day of screening and day 1. * use of a 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 (see the table below). 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 sterilized (including bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or * postmenopausal * for women aged \< 50 years old, postmenopause is defined as having both: * a history ≥ 12 months amenorrhea prior to the first dosing, without an alternative cause, following cessation of exogenous sex hormone treatment and * a follicle-stimulating hormone level in post-menopausal range. (until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential.) * for women aged ≥ 50 years old, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex hormone treatment. 4. 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. 12, 2022, 9 a.m. usa

inclusion criteria: participants are: overtly healthy as determined by medical examination, 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. (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. female participants women of childbearing potential must: have a negative pregnancy test on the day of screening and day 1. use of a 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 (see the table below). 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 sterilized (including bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal for women aged < 50 years old, postmenopause is defined as having both: a history ≥ 12 months amenorrhea prior to the first dosing, without an alternative cause, following cessation of exogenous sex hormone treatment and a follicle-stimulating hormone level in post-menopausal range. (until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential.) for women aged ≥ 50 years old, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex hormone treatment. 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: participants are: overtly healthy as determined by medical examination, 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. (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. female participants women of childbearing potential must: have a negative pregnancy test on the day of screening and day 1. use of a 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 (see the table below). 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 sterilized (including bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal for women aged < 50 years old, postmenopause is defined as having both: a history ≥ 12 months amenorrhea prior to the first dosing, without an alternative cause, following cessation of exogenous sex hormone treatment and a follicle-stimulating hormone level in post-menopausal range. (until follicle-stimulating hormone is documented to be within menopausal range, the participant is to be considered of childbearing potential.) for women aged ≥ 50 years old, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex hormone treatment. 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: agree to sign the study informed consent form (icf) before performing any study-specific procedure healthy or medically stable, when, in the opinion of the investigator, no hospitalization is expected during the study period, and the participant is likely to be able to take part in the study until the end of the observation period specified in the protocol. a stable medical condition is defined as a disease that did not require significant changes in therapy or hospitalization 3 months before inclusion. the ability to understand and comply with the protocol requirements in the investigator's opinion female participants for female participants of childbearing potential the following is required: a negative pregnancy test result on the day of screening and on day 1. use appropriate contraception through 28 days before day 1 and through 60 days following administration of the second dose female participants have the childbearing potential if they do not meet any of the following criteria: surgical sterilization (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or postmenopause for women under the age of 50, postmenopause is defined as having two of the following criteria: amenorrhea ≥ 12 months before the first dose, with no alternative cause, after discontinuation of exogenous sex hormone therapy, and level of follicle-stimulating hormone in the postmenopausal range

inclusion criteria: agree to sign the study informed consent form (icf) before performing any study-specific procedure healthy or medically stable, when, in the opinion of the investigator, no hospitalization is expected during the study period, and the participant is likely to be able to take part in the study until the end of the observation period specified in the protocol. a stable medical condition is defined as a disease that did not require significant changes in therapy or hospitalization 3 months before inclusion. the ability to understand and comply with the protocol requirements in the investigator's opinion female participants for female participants of childbearing potential the following is required: a negative pregnancy test result on the day of screening and on day 1. use appropriate contraception through 28 days before day 1 and through 60 days following administration of the second dose female participants have the childbearing potential if they do not meet any of the following criteria: surgical sterilization (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or postmenopause for women under the age of 50, postmenopause is defined as having two of the following criteria: amenorrhea ≥ 12 months before the first dose, with no alternative cause, after discontinuation of exogenous sex hormone therapy, and level of follicle-stimulating hormone in the postmenopausal range

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

inclusion criteria: - agree to sign the study informed consent form (icf) before performing any study-specific procedure - healthy or medically stable, when, in the opinion of the investigator, no hospitalization is expected during the study period, and the participant is likely to be able to take part in the study until the end of the observation period specified in the protocol. - a stable medical condition is defined as a disease that did not require significant changes in therapy or hospitalization 3 months before inclusion. - the ability to understand and comply with the protocol requirements in the investigator's opinion - female participants 1. for female participants of childbearing potential the following is required: - a negative pregnancy test result on the day of screening and on day 1. - use appropriate contraception through 28 days before day 1 and through 60 days following administration of the second dose 2. female participants have the childbearing potential if they do not meet any of the following criteria: - surgical sterilization (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or - postmenopause - for women under the age of 50, postmenopause is defined as having two of the following criteria: - amenorrhea ≥ 12 months before the first dose, with no alternative cause, after discontinuation of exogenous sex hormone therapy, and - level of follicle-stimulating hormone in the postmenopausal range

inclusion criteria: - agree to sign the study informed consent form (icf) before performing any study-specific procedure - healthy or medically stable, when, in the opinion of the investigator, no hospitalization is expected during the study period, and the participant is likely to be able to take part in the study until the end of the observation period specified in the protocol. - a stable medical condition is defined as a disease that did not require significant changes in therapy or hospitalization 3 months before inclusion. - the ability to understand and comply with the protocol requirements in the investigator's opinion - female participants 1. for female participants of childbearing potential the following is required: - a negative pregnancy test result on the day of screening and on day 1. - use appropriate contraception through 28 days before day 1 and through 60 days following administration of the second dose 2. female participants have the childbearing potential if they do not meet any of the following criteria: - surgical sterilization (including bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or - postmenopause - for women under the age of 50, postmenopause is defined as having two of the following criteria: - amenorrhea ≥ 12 months before the first dose, with no alternative cause, after discontinuation of exogenous sex hormone therapy, and - level of follicle-stimulating hormone in the postmenopausal range