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

inclusion criteria: * male or female participants 18 years of age or older. * be willing and able to provide written informed consent prior to initiation of any trial procedures. * expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit. * females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening (day 1) without an alternative medical cause}. a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. * females of childbearing potential: negative pregnancy test (human chorionic gonadotropin \[hcg\]) within 24 hours prior to each trial vaccination on day 1 and day 29. * females of childbearing potential must use highly effective methods of birth control from 2 weeks 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; * intrauterine hormone-releasing systems; * bilateral tubal ligation; * vasectomized or infertile partner; * sexual abstinence {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) and withdrawal are not acceptable}.

inclusion criteria: * male or female participants 18 years of age or older. * be willing and able to provide written informed consent prior to initiation of any trial procedures. * expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit. * females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening (day 1) without an alternative medical cause}. a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. * females of childbearing potential: negative pregnancy test (human chorionic gonadotropin \[hcg\]) within 24 hours prior to each trial vaccination on day 1 and day 29. * females of childbearing potential must use highly effective methods of birth control from 2 weeks 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; * intrauterine hormone-releasing systems; * bilateral tubal ligation; * vasectomized or infertile partner; * sexual abstinence {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) and withdrawal are not acceptable}.

March 8, 2022, 10:30 p.m. usa

inclusion criteria: male or female participants 18 years of age or older. be willing and able to provide written informed consent prior to initiation of any trial procedures. expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit. females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening (day 1) without an alternative medical cause}. a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. females of childbearing potential: negative pregnancy test (human chorionic gonadotropin [hcg]) within 24 hours prior to each trial vaccination on day 1 and day 29. females of childbearing potential must use highly effective methods of birth control from 2 weeks 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; intrauterine hormone-releasing systems; bilateral tubal ligation; vasectomized or infertile partner; sexual abstinence {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) and withdrawal are not acceptable}.

inclusion criteria: male or female participants 18 years of age or older. be willing and able to provide written informed consent prior to initiation of any trial procedures. expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit. females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening (day 1) without an alternative medical cause}. a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. females of childbearing potential: negative pregnancy test (human chorionic gonadotropin [hcg]) within 24 hours prior to each trial vaccination on day 1 and day 29. females of childbearing potential must use highly effective methods of birth control from 2 weeks 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; intrauterine hormone-releasing systems; bilateral tubal ligation; vasectomized or infertile partner; sexual abstinence {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) and withdrawal are not acceptable}.

May 21, 2021, 12:31 a.m. usa

inclusion criteria: - male or female participants 18 years of age or older. - be willing and able to provide written informed consent prior to initiation of any trial procedures. - expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit. - females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening (day 1) without an alternative medical cause}. a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. - females of childbearing potential: negative pregnancy test (human chorionic gonadotropin [hcg]) within 24 hours prior to each trial vaccination on day 1 and day 29. - females of childbearing potential must use highly effective methods of birth control from 2 weeks 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 ligation; - vasectomized or infertile partner; - sexual abstinence {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) and withdrawal are not acceptable}.

inclusion criteria: - male or female participants 18 years of age or older. - be willing and able to provide written informed consent prior to initiation of any trial procedures. - expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit. - females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening (day 1) without an alternative medical cause}. a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. - females of childbearing potential: negative pregnancy test (human chorionic gonadotropin [hcg]) within 24 hours prior to each trial vaccination on day 1 and day 29. - females of childbearing potential must use highly effective methods of birth control from 2 weeks 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 ligation; - vasectomized or infertile partner; - sexual abstinence {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) and withdrawal are not acceptable}.

Dec. 5, 2020, 12:31 a.m. usa

inclusion criteria: - male or female participants 18 years of age or older. - provide written informed consent prior to initiation of any trial procedures. - expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit. - females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening (day 1) without an alternative medical cause}. a follicle- stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. - females of childbearing potential: negative urine pregnancy test (hcg) within 24 hours prior to each trial vaccination on day 1 and day 29. - females of childbearing potential must use highly effective methods of birth control from 2 weeks 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 or infertile partner; - sexual abstinence {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) and withdrawal are not acceptable}.

inclusion criteria: - male or female participants 18 years of age or older. - provide written informed consent prior to initiation of any trial procedures. - expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit. - females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening (day 1) without an alternative medical cause}. a follicle- stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. - females of childbearing potential: negative urine pregnancy test (hcg) within 24 hours prior to each trial vaccination on day 1 and day 29. - females of childbearing potential must use highly effective methods of birth control from 2 weeks 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 or infertile partner; - sexual abstinence {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) and withdrawal are not acceptable}.