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

inclusion criteria: * healthy male and female participants ≥18 years of age. a healthy participant is defined as an individual who is in good general health, according to the investigator's assessment. chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the investigator. * expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. * participants are able to understand and willing to provide informed consent. * physical examination without clinically significant findings according to the investigator's assessment. * body mass index (bmi) ≥18.0 and ≤32.0 kg/m\^2. * female participants of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hcg) pregnancy test (serum) for female participants presumed to be of childbearing potential on the day of enrollment. on day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before). * female participants 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 occlusion; * vasectomized partner; * sexual abstinence (periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable). * male participants should be instructed not to get their partners pregnant until 3 months after the last administration.

inclusion criteria: * healthy male and female participants ≥18 years of age. a healthy participant is defined as an individual who is in good general health, according to the investigator's assessment. chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the investigator. * expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. * participants are able to understand and willing to provide informed consent. * physical examination without clinically significant findings according to the investigator's assessment. * body mass index (bmi) ≥18.0 and ≤32.0 kg/m\^2. * female participants of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hcg) pregnancy test (serum) for female participants presumed to be of childbearing potential on the day of enrollment. on day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before). * female participants 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 occlusion; * vasectomized partner; * sexual abstinence (periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable). * male participants should be instructed not to get their partners pregnant until 3 months after the last administration.

Nov. 30, 2021, 11 p.m. usa

inclusion criteria: healthy male and female participants ≥18 years of age. a healthy participant is defined as an individual who is in good general health, according to the investigator's assessment. chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the investigator. expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. participants are able to understand and willing to provide informed consent. physical examination without clinically significant findings according to the investigator's assessment. body mass index (bmi) ≥18.0 and ≤32.0 kg/m^2. female participants of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hcg) pregnancy test (serum) for female participants presumed to be of childbearing potential on the day of enrollment. on day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before). female participants 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 occlusion; vasectomized partner; sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable). male participants should be instructed not to get their partners pregnant until 3 months after the last administration.

inclusion criteria: healthy male and female participants ≥18 years of age. a healthy participant is defined as an individual who is in good general health, according to the investigator's assessment. chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the investigator. expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. participants are able to understand and willing to provide informed consent. physical examination without clinically significant findings according to the investigator's assessment. body mass index (bmi) ≥18.0 and ≤32.0 kg/m^2. female participants of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hcg) pregnancy test (serum) for female participants presumed to be of childbearing potential on the day of enrollment. on day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before). female participants 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 occlusion; vasectomized partner; sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable). male participants should be instructed not to get their partners pregnant until 3 months after the last administration.

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

inclusion criteria: - healthy male and female participants ≥18 years of age. a healthy participant is defined as an individual who is in good general health, according to the investigator's assessment. chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the investigator. - expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. - physical examination without clinically significant findings according to the investigator's assessment. - body mass index (bmi) ≥18.0 and ≤32.0 kg/m^2. - female participants of childbearing potential: 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 (required if serum pregnancy test was performed more than 3 days before). - female participants 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 occlusion; - vasectomized partner; - sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable). - male participants should be instructed not to get their partners pregnant during the study.

inclusion criteria: - healthy male and female participants ≥18 years of age. a healthy participant is defined as an individual who is in good general health, according to the investigator's assessment. chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the investigator. - expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. - physical examination without clinically significant findings according to the investigator's assessment. - body mass index (bmi) ≥18.0 and ≤32.0 kg/m^2. - female participants of childbearing potential: 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 (required if serum pregnancy test was performed more than 3 days before). - female participants 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 occlusion; - vasectomized partner; - sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable). - male participants should be instructed not to get their partners pregnant during the study.

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: - healthy male and female participants ≥18 years of age. a healthy participant is defined as an individual who is in good general health, according to the investigator's assessment. chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the investigator. - expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. - physical examination without clinically significant findings according to the investigator's assessment. - body mass index (bmi) ≥18.0 and ≤30.0 kg/m^2. - female participants of childbearing potential: 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 (required if serum pregnancy test was performed more than 3 days before). - female participants 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 occlusion; - vasectomized partner; - sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable).

inclusion criteria: - healthy male and female participants ≥18 years of age. a healthy participant is defined as an individual who is in good general health, according to the investigator's assessment. chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the investigator. - expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit. - physical examination without clinically significant findings according to the investigator's assessment. - body mass index (bmi) ≥18.0 and ≤30.0 kg/m^2. - female participants of childbearing potential: 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 (required if serum pregnancy test was performed more than 3 days before). - female participants 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 occlusion; - vasectomized partner; - sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and post-ovulation methods] and withdrawal are not acceptable).