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

inclusion criteria: 1. male or female participants between the ages of 18 and 45 years or aged 65 years and older. 2. healthy adults or adults with pre-existing medical conditions who are in a stable condition. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment. 3. capable of giving personal signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this study protocol. 4. physical examination without clinically significant findings according to the investigator's assessment. 5. affiliated to a social security system (except state medical aid). 6. 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 serum pregnancy test was performed more than 3 days before). note: women that are postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening \[day 1\]) or permanently sterilized will be considered as not having reproductive potential. 7. females of childbearing potential must use highly effective 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. * same sex relationships. sexual abstinence (periodic abstinence \[e.g., calendar, ovulation symptothermal and post-ovulation methods\]) and withdrawal are not acceptable methods.

inclusion criteria: 1. male or female participants between the ages of 18 and 45 years or aged 65 years and older. 2. healthy adults or adults with pre-existing medical conditions who are in a stable condition. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment. 3. capable of giving personal signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this study protocol. 4. physical examination without clinically significant findings according to the investigator's assessment. 5. affiliated to a social security system (except state medical aid). 6. 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 serum pregnancy test was performed more than 3 days before). note: women that are postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening \[day 1\]) or permanently sterilized will be considered as not having reproductive potential. 7. females of childbearing potential must use highly effective 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. * same sex relationships. sexual abstinence (periodic abstinence \[e.g., calendar, ovulation symptothermal and post-ovulation methods\]) and withdrawal are not acceptable methods.

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

inclusion criteria: male or female participants between the ages of 18 and 45 years or aged 65 years and older. healthy adults or adults with pre-existing medical conditions who are in a stable condition. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment. capable of giving personal signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this study protocol. physical examination without clinically significant findings according to the investigator's assessment. affiliated to a social security system (except state medical aid). 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 serum pregnancy test was performed more than 3 days before). note: women that are postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening [day 1]) or permanently sterilized will be considered as not having reproductive potential. females of childbearing potential must use highly effective 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. same sex relationships. sexual abstinence (periodic abstinence [e.g., calendar, ovulation symptothermal and post-ovulation methods]) and withdrawal are not acceptable methods.

inclusion criteria: male or female participants between the ages of 18 and 45 years or aged 65 years and older. healthy adults or adults with pre-existing medical conditions who are in a stable condition. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment. capable of giving personal signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this study protocol. physical examination without clinically significant findings according to the investigator's assessment. affiliated to a social security system (except state medical aid). 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 serum pregnancy test was performed more than 3 days before). note: women that are postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening [day 1]) or permanently sterilized will be considered as not having reproductive potential. females of childbearing potential must use highly effective 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. same sex relationships. sexual abstinence (periodic abstinence [e.g., calendar, ovulation symptothermal and post-ovulation methods]) and withdrawal are not acceptable methods.

April 11, 2021, 12:31 a.m. usa

inclusion criteria: 1. male or female participants between the ages of 18 and 45 years or aged 65 years and older. 2. healthy adults or adults with pre-existing medical conditions who are in a stable condition. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment. 3. capable of giving personal signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this study protocol. 4. physical examination without clinically significant findings according to the investigator's assessment. 5. affiliated to a social security system (except state medical aid). 6. 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 serum pregnancy test was performed more than 3 days before). note: women that are postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening [day 1]) or permanently sterilized will be considered as not having reproductive potential. 7. females of childbearing potential must use highly effective 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. - same sex relationships. sexual abstinence (periodic abstinence [e.g., calendar, ovulation symptothermal and post-ovulation methods]) and withdrawal are not acceptable methods.

inclusion criteria: 1. male or female participants between the ages of 18 and 45 years or aged 65 years and older. 2. healthy adults or adults with pre-existing medical conditions who are in a stable condition. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment. 3. capable of giving personal signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this study protocol. 4. physical examination without clinically significant findings according to the investigator's assessment. 5. affiliated to a social security system (except state medical aid). 6. 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 serum pregnancy test was performed more than 3 days before). note: women that are postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening [day 1]) or permanently sterilized will be considered as not having reproductive potential. 7. females of childbearing potential must use highly effective 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. - same sex relationships. sexual abstinence (periodic abstinence [e.g., calendar, ovulation symptothermal and post-ovulation methods]) and withdrawal are not acceptable methods.