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

inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: 1. participants are: * 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. (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 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 * for women aged \< 50 years, postmenopausal is defined as having both: * a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and * a follicle-stimulating hormone level in the 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, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal 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 the protocol of the sudy.

inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: 1. participants are: * 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. (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 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 * for women aged \< 50 years, postmenopausal is defined as having both: * a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and * a follicle-stimulating hormone level in the 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, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal 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 the protocol of the sudy.

Dec. 22, 2021, 3 a.m. usa

inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: participants are: 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. (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 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 for women aged < 50 years, postmenopausal is defined as having both: a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and a follicle-stimulating hormone level in the 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, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in the protocol of the sudy.

inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: participants are: 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. (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 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 for women aged < 50 years, postmenopausal is defined as having both: a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and a follicle-stimulating hormone level in the 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, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in the protocol of the sudy.

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

inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: capable to sign the study informed consent form (icf) before performing any study-specific procedure participants who are overtly healthy as determined by medical evaluation, or medically stable such that, according to the judgment of the investigator, hospitalization 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.) ability 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 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 for women aged < 50 years, postmenopausal is defined as having both: a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and a follicle-stimulating hormone level in the 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, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment

inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: capable to sign the study informed consent form (icf) before performing any study-specific procedure participants who are overtly healthy as determined by medical evaluation, or medically stable such that, according to the judgment of the investigator, hospitalization 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.) ability 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 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 for women aged < 50 years, postmenopausal is defined as having both: a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and a follicle-stimulating hormone level in the 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, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment

Feb. 20, 2021, 12:31 a.m. usa

inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: - capable to sign the study informed consent form (icf) before performing any study-specific procedure - participants who are overtly healthy as determined by medical evaluation, or medically stable such that, according to the judgment of the investigator, hospitalization 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.) - ability to understand and comply with study requirements/procedures based on the assessment of the investigator. - 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 - for women aged < 50 years, postmenopausal is defined as having both: - a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and - a follicle-stimulating hormone level in the 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, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment

inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: - capable to sign the study informed consent form (icf) before performing any study-specific procedure - participants who are overtly healthy as determined by medical evaluation, or medically stable such that, according to the judgment of the investigator, hospitalization 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.) - ability to understand and comply with study requirements/procedures based on the assessment of the investigator. - 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 - for women aged < 50 years, postmenopausal is defined as having both: - a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment, and - a follicle-stimulating hormone level in the 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, postmenopausal is defined as having a history of ≥ 12 months amenorrhea prior to first dosing, without an alternative cause, following cessation of exogenous sex-hormonal treatment