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

inclusion criteria: 1. males and females between the ages of 18 and 55 years (at the time of consent). 2. healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments 3. participant with a body mass index (bmi) \<30.0 kg/m2 4. provide written informed consent before initiation of any study procedures. 5. a female participant is eligible for this study if she is not pregnant, given by a negative serum pregnancy test at screening and a negative urine pregnancy test at v1 (1st injection), or breast feeding and 1 of the following: * of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year). * of childbearing potential but has been and agrees to continue practicing highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 6 months after the last injection (d210). * highly effective methods of contraception include 1 or more of the following: * male partner who is sterile (vasectomised) prior to the female participants entry into the study and is the sole sexual partner for the female participant; * hormonal (oral, intravaginal, transdermal, implantable or injectable); * an intrauterine hormone-releasing system (ius); * an intrauterine device (iud) with a documented failure rate of \< 1%. 6. a female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 6 months after the last injection (d210); 7. a male participant who is sexually active is eligible if he is willing to : * use a condom (with/without spermicidal product) from the screening visit up to 6 months after the last injection (d210) except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal (defined as no menses for 12 months without an alternative medical cause), is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective methods of contraception; * not donate sperm from the screening visit up to 6 months after the last injection (d210); * not plan to father a child from the screening visit up to 6 months after the last injection (d210). 8. negative hiv 1/2 antibody/antigen test, hepatitis b surface antigen (hbsag), and hepatitis c virus (hcv) antibody. 9. able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study. 10. willing to abstain from donating whole blood or blood derivatives, tissue or organ all along the study. 11. affiliated to a social security system, (except state medical aid) (only for france). 12. volunteer registered in the french health ministry computerized file and authorized to participate in a clinical trial (only for france).

inclusion criteria: 1. males and females between the ages of 18 and 55 years (at the time of consent). 2. healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments 3. participant with a body mass index (bmi) \<30.0 kg/m2 4. provide written informed consent before initiation of any study procedures. 5. a female participant is eligible for this study if she is not pregnant, given by a negative serum pregnancy test at screening and a negative urine pregnancy test at v1 (1st injection), or breast feeding and 1 of the following: * of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year). * of childbearing potential but has been and agrees to continue practicing highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 6 months after the last injection (d210). * highly effective methods of contraception include 1 or more of the following: * male partner who is sterile (vasectomised) prior to the female participants entry into the study and is the sole sexual partner for the female participant; * hormonal (oral, intravaginal, transdermal, implantable or injectable); * an intrauterine hormone-releasing system (ius); * an intrauterine device (iud) with a documented failure rate of \< 1%. 6. a female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 6 months after the last injection (d210); 7. a male participant who is sexually active is eligible if he is willing to : * use a condom (with/without spermicidal product) from the screening visit up to 6 months after the last injection (d210) except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal (defined as no menses for 12 months without an alternative medical cause), is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective methods of contraception; * not donate sperm from the screening visit up to 6 months after the last injection (d210); * not plan to father a child from the screening visit up to 6 months after the last injection (d210). 8. negative hiv 1/2 antibody/antigen test, hepatitis b surface antigen (hbsag), and hepatitis c virus (hcv) antibody. 9. able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study. 10. willing to abstain from donating whole blood or blood derivatives, tissue or organ all along the study. 11. affiliated to a social security system, (except state medical aid) (only for france). 12. volunteer registered in the french health ministry computerized file and authorized to participate in a clinical trial (only for france).

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

inclusion criteria: males and females between the ages of 18 and 55 years (at the time of consent). healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments participant with a body mass index (bmi) <30.0 kg/m2 provide written informed consent before initiation of any study procedures. a female participant is eligible for this study if she is not pregnant, given by a negative serum pregnancy test at screening and a negative urine pregnancy test at v1 (1st injection), or breast feeding and 1 of the following: of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year). of childbearing potential but has been and agrees to continue practicing highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 6 months after the last injection (d210). highly effective methods of contraception include 1 or more of the following: male partner who is sterile (vasectomised) prior to the female participants entry into the study and is the sole sexual partner for the female participant; hormonal (oral, intravaginal, transdermal, implantable or injectable); an intrauterine hormone-releasing system (ius); an intrauterine device (iud) with a documented failure rate of < 1%. a female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 6 months after the last injection (d210); a male participant who is sexually active is eligible if he is willing to : use a condom (with/without spermicidal product) from the screening visit up to 6 months after the last injection (d210) except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal (defined as no menses for 12 months without an alternative medical cause), is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective methods of contraception; not donate sperm from the screening visit up to 6 months after the last injection (d210); not plan to father a child from the screening visit up to 6 months after the last injection (d210). negative hiv 1/2 antibody/antigen test, hepatitis b surface antigen (hbsag), and hepatitis c virus (hcv) antibody. able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study. willing to abstain from donating whole blood or blood derivatives, tissue or organ all along the study. affiliated to a social security system, (except state medical aid) (only for france). volunteer registered in the french health ministry computerized file and authorized to participate in a clinical trial (only for france).

inclusion criteria: males and females between the ages of 18 and 55 years (at the time of consent). healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments participant with a body mass index (bmi) <30.0 kg/m2 provide written informed consent before initiation of any study procedures. a female participant is eligible for this study if she is not pregnant, given by a negative serum pregnancy test at screening and a negative urine pregnancy test at v1 (1st injection), or breast feeding and 1 of the following: of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year). of childbearing potential but has been and agrees to continue practicing highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 6 months after the last injection (d210). highly effective methods of contraception include 1 or more of the following: male partner who is sterile (vasectomised) prior to the female participants entry into the study and is the sole sexual partner for the female participant; hormonal (oral, intravaginal, transdermal, implantable or injectable); an intrauterine hormone-releasing system (ius); an intrauterine device (iud) with a documented failure rate of < 1%. a female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 6 months after the last injection (d210); a male participant who is sexually active is eligible if he is willing to : use a condom (with/without spermicidal product) from the screening visit up to 6 months after the last injection (d210) except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal (defined as no menses for 12 months without an alternative medical cause), is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective methods of contraception; not donate sperm from the screening visit up to 6 months after the last injection (d210); not plan to father a child from the screening visit up to 6 months after the last injection (d210). negative hiv 1/2 antibody/antigen test, hepatitis b surface antigen (hbsag), and hepatitis c virus (hcv) antibody. able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study. willing to abstain from donating whole blood or blood derivatives, tissue or organ all along the study. affiliated to a social security system, (except state medical aid) (only for france). volunteer registered in the french health ministry computerized file and authorized to participate in a clinical trial (only for france).

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

inclusion criteria: 1. males and females between the ages of 18 and 55 years (at the time of consent). 2. healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments 3. participant with a body mass index (bmi) <30.0 kg/m2 4. provide written informed consent before initiation of any study procedures. 5. a female participant is eligible for this study if she is not pregnant, given by a negative serum pregnancy test at screening and a negative urine pregnancy test at v1 (1st injection), or breast feeding and 1 of the following: - of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year). - of childbearing potential but has been and agrees to continue practicing highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 6 months after the last injection (d210). - highly effective methods of contraception include 1 or more of the following: - male partner who is sterile (vasectomised) prior to the female participants entry into the study and is the sole sexual partner for the female participant; - hormonal (oral, intravaginal, transdermal, implantable or injectable); - an intrauterine hormone-releasing system (ius); - an intrauterine device (iud) with a documented failure rate of < 1%. 6. a female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 6 months after the last injection (d210); 7. a male participant who is sexually active is eligible if he is willing to : - use a condom (with/without spermicidal product) from the screening visit up to 6 months after the last injection (d210) except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal (defined as no menses for 12 months without an alternative medical cause), is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective methods of contraception; - not donate sperm from the screening visit up to 6 months after the last injection (d210); - not plan to father a child from the screening visit up to 6 months after the last injection (d210). 8. negative hiv 1/2 antibody/antigen test, hepatitis b surface antigen (hbsag), and hepatitis c virus (hcv) antibody. 9. able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study. 10. willing to abstain from donating whole blood or blood derivatives, tissue or organ all along the study. 11. affiliated to a social security system, (except state medical aid) (only for france). 12. volunteer registered in the french health ministry computerized file and authorized to participate in a clinical trial (only for france).

inclusion criteria: 1. males and females between the ages of 18 and 55 years (at the time of consent). 2. healthy participant, according to the investigator's clinical judgment, as established by medical history, vital signs, physical examination, and laboratory assessments 3. participant with a body mass index (bmi) <30.0 kg/m2 4. provide written informed consent before initiation of any study procedures. 5. a female participant is eligible for this study if she is not pregnant, given by a negative serum pregnancy test at screening and a negative urine pregnancy test at v1 (1st injection), or breast feeding and 1 of the following: - of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year). - of childbearing potential but has been and agrees to continue practicing highly effective contraception or abstinence (if this is the preferred and usual lifestyle of the participant) from 30 days prior to vaccination up to 6 months after the last injection (d210). - highly effective methods of contraception include 1 or more of the following: - male partner who is sterile (vasectomised) prior to the female participants entry into the study and is the sole sexual partner for the female participant; - hormonal (oral, intravaginal, transdermal, implantable or injectable); - an intrauterine hormone-releasing system (ius); - an intrauterine device (iud) with a documented failure rate of < 1%. 6. a female participant is eligible if she is willing to abstain from donating oocyte from the screening visit up to 6 months after the last injection (d210); 7. a male participant who is sexually active is eligible if he is willing to : - use a condom (with/without spermicidal product) from the screening visit up to 6 months after the last injection (d210) except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal (defined as no menses for 12 months without an alternative medical cause), is permanently sterilized (e.g. hysterectomy or tubal ligation), or use a highly effective methods of contraception; - not donate sperm from the screening visit up to 6 months after the last injection (d210); - not plan to father a child from the screening visit up to 6 months after the last injection (d210). 8. negative hiv 1/2 antibody/antigen test, hepatitis b surface antigen (hbsag), and hepatitis c virus (hcv) antibody. 9. able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study. 10. willing to abstain from donating whole blood or blood derivatives, tissue or organ all along the study. 11. affiliated to a social security system, (except state medical aid) (only for france). 12. volunteer registered in the french health ministry computerized file and authorized to participate in a clinical trial (only for france).