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

inclusion criteria * subjects eligible to participate in this trial had to meet all of the following inclusion criteria: * provide written informed consent prior to initiation of any study procedures. * healthy males or non-pregnant females, aged 18 years to 65 years inclusive. * women of childbearing potential2 must use an acceptable contraception method3 from at least 30 days before study vaccination until 90 days after study vaccination. 2not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year has passed since the last menses if menopausal. 3includes full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more barrier methods such as condoms, effective intrauterine devices, tubal ligation, and approved hormonal methods such as implants, injectables or oral contraceptives ("the pill"). * women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination * are able to understand and comply with planned study procedures and be available for all study visits. exclusion criteria * • have an acute illness, as determined by the site principal investigator (pi) or appropriate sub-investigator, within 72 hours prior to study vaccination. * have a history of documented covid-19 infection or a known positive covid-19 antibody test. * liver function tests (alt, ast or ggt) \> 2 times upper limit of normal * egfr \<55 ml/min/1.73 m2 * have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy. * use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination. * have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. * have known human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection. * have a history of severe systemic reactions following previous immunization with licensed or unlicensed vaccines. * have a history of guillain-barré syndrome. * have known hypersensitivity or allergy to insect stings or other components of the study vaccine. * have a history of epilepsy or febrile convulsions * have a history of potentially immune-mediated medical conditions (pimmcs). * have a history of alcohol or drug abuse within 5 years prior to study vaccination. * have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations as determined by the site pi or appropriate sub-investigator. * have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination. * have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination. * have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. * female participants who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination. * positive urine or serum pregnancy test within 24 hours prior to any study vaccination * received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period. * have any medical disease or condition that, in the opinion of the investigator, is a contraindication to study participation. * have any medical disease or condition that, in the opinion of the site pi or appropriate sub-investigator, is a contraindication to study participation. \*including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. * any participant whose enrolment, in the opinion of the investigator, would be detrimental to the participant or the study.

inclusion criteria * subjects eligible to participate in this trial had to meet all of the following inclusion criteria: * provide written informed consent prior to initiation of any study procedures. * healthy males or non-pregnant females, aged 18 years to 65 years inclusive. * women of childbearing potential2 must use an acceptable contraception method3 from at least 30 days before study vaccination until 90 days after study vaccination. 2not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year has passed since the last menses if menopausal. 3includes full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more barrier methods such as condoms, effective intrauterine devices, tubal ligation, and approved hormonal methods such as implants, injectables or oral contraceptives ("the pill"). * women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination * are able to understand and comply with planned study procedures and be available for all study visits. exclusion criteria * • have an acute illness, as determined by the site principal investigator (pi) or appropriate sub-investigator, within 72 hours prior to study vaccination. * have a history of documented covid-19 infection or a known positive covid-19 antibody test. * liver function tests (alt, ast or ggt) \> 2 times upper limit of normal * egfr \<55 ml/min/1.73 m2 * have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy. * use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination. * have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. * have known human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection. * have a history of severe systemic reactions following previous immunization with licensed or unlicensed vaccines. * have a history of guillain-barré syndrome. * have known hypersensitivity or allergy to insect stings or other components of the study vaccine. * have a history of epilepsy or febrile convulsions * have a history of potentially immune-mediated medical conditions (pimmcs). * have a history of alcohol or drug abuse within 5 years prior to study vaccination. * have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations as determined by the site pi or appropriate sub-investigator. * have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination. * have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination. * have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. * female participants who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination. * positive urine or serum pregnancy test within 24 hours prior to any study vaccination * received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period. * have any medical disease or condition that, in the opinion of the investigator, is a contraindication to study participation. * have any medical disease or condition that, in the opinion of the site pi or appropriate sub-investigator, is a contraindication to study participation. \*including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. * any participant whose enrolment, in the opinion of the investigator, would be detrimental to the participant or the study.

May 8, 2021, 12:31 a.m. usa

inclusion criteria - subjects eligible to participate in this trial had to meet all of the following inclusion criteria: - provide written informed consent prior to initiation of any study procedures. - healthy males or non-pregnant females, aged 18 years to 65 years inclusive. - women of childbearing potential2 must use an acceptable contraception method3 from at least 30 days before study vaccination until 90 days after study vaccination. 2not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses if menopausal. 3includes full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more barrier methods such as condoms, effective intrauterine devices, tubal ligation, and approved hormonal methods such as implants, injectables or oral contraceptives ("the pill"). - women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination - are able to understand and comply with planned study procedures and be available for all study visits. exclusion criteria - • have an acute illness, as determined by the site principal investigator (pi) or appropriate sub-investigator, within 72 hours prior to study vaccination. - have a history of documented covid-19 infection or a known positive covid-19 antibody test. - liver function tests (alt, ast or ggt) > 2 times upper limit of normal - egfr <55 ml/min/1.73 m2 - have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy. - use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination. - have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. - have known human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection. - have a history of severe systemic reactions following previous immunization with licensed or unlicensed vaccines. - have a history of guillain-barré syndrome. - have known hypersensitivity or allergy to insect stings or other components of the study vaccine. - have a history of epilepsy or febrile convulsions - have a history of potentially immune-mediated medical conditions (pimmcs). - have a history of alcohol or drug abuse within 5 years prior to study vaccination. - have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations as determined by the site pi or appropriate sub-investigator. - have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination. - have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination. - have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. - female participants who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination. - positive urine or serum pregnancy test within 24 hours prior to any study vaccination - received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period. - have any medical disease or condition that, in the opinion of the investigator, is a contraindication to study participation. - have any medical disease or condition that, in the opinion of the site pi or appropriate sub-investigator, is a contraindication to study participation. *including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. - any participant whose enrolment, in the opinion of the investigator, would be detrimental to the participant or the study.

inclusion criteria - subjects eligible to participate in this trial had to meet all of the following inclusion criteria: - provide written informed consent prior to initiation of any study procedures. - healthy males or non-pregnant females, aged 18 years to 65 years inclusive. - women of childbearing potential2 must use an acceptable contraception method3 from at least 30 days before study vaccination until 90 days after study vaccination. 2not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses if menopausal. 3includes full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more barrier methods such as condoms, effective intrauterine devices, tubal ligation, and approved hormonal methods such as implants, injectables or oral contraceptives ("the pill"). - women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination - are able to understand and comply with planned study procedures and be available for all study visits. exclusion criteria - • have an acute illness, as determined by the site principal investigator (pi) or appropriate sub-investigator, within 72 hours prior to study vaccination. - have a history of documented covid-19 infection or a known positive covid-19 antibody test. - liver function tests (alt, ast or ggt) > 2 times upper limit of normal - egfr <55 ml/min/1.73 m2 - have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy. - use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination. - have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. - have known human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection. - have a history of severe systemic reactions following previous immunization with licensed or unlicensed vaccines. - have a history of guillain-barré syndrome. - have known hypersensitivity or allergy to insect stings or other components of the study vaccine. - have a history of epilepsy or febrile convulsions - have a history of potentially immune-mediated medical conditions (pimmcs). - have a history of alcohol or drug abuse within 5 years prior to study vaccination. - have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations as determined by the site pi or appropriate sub-investigator. - have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination. - have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination. - have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. - female participants who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination. - positive urine or serum pregnancy test within 24 hours prior to any study vaccination - received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period. - have any medical disease or condition that, in the opinion of the investigator, is a contraindication to study participation. - have any medical disease or condition that, in the opinion of the site pi or appropriate sub-investigator, is a contraindication to study participation. *including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. - any participant whose enrolment, in the opinion of the investigator, would be detrimental to the participant or the study.

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

inclusion criteria - are males or non-pregnant females, 18 years of age or older. - provide written informed consent prior to initiation of any study procedures. - are able to understand and comply with planned study procedures and be available for all study visits. - are in good health as determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations in the opinion of the investigator. - screening laboratory bloods - white blood cells (wbc), hemoglobin (hgb), platelets (plts), alanine aminotransferase (alt), total bilirubin (t. bili), aspartate aminotransferase (ast), gamma-glutamyl transferase (ggt), and creatinine (cr)) are within acceptable parameters as determined by the investigator - women of childbearing potential must use an acceptable contraception method and must have a negative urine or serum pregnancy test within 24 hours prior to the first study vaccination. exclusion criteria - have an acute illness, as determined by the site principal investigator (pi) or appropriate sub-investigator, within 72 hours prior to study vaccination. - have any medical disease or condition that, in the opinion of the site pi or appropriate sub-investigator, is a contraindication to study participation. *including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. - have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy. - use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination. - have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. non-melanoma, treated, skin cancers are permitted. - have known human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection. - have known hypersensitivity or allergy to insect stings or other components of the study vaccine. - have a history of severe reactions following previous immunization with licensed or unlicensed vaccines. - have a history of guillain-barré syndrome. - have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination. - have a history of potentially immune-mediated medical conditions (pimmcs). - have a history of alcohol or drug abuse within 5 years prior to study vaccination. - have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations as determined by the site pi or appropriate sub-investigator. - have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination. - have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination. - have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. - have a known history of documented covid-19 infection within the past 6 months. - received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period. - female participants who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination. - any participant whose enrolment, in the opinion of the investigator, would be detrimental to the participant or the study.

inclusion criteria - are males or non-pregnant females, 18 years of age or older. - provide written informed consent prior to initiation of any study procedures. - are able to understand and comply with planned study procedures and be available for all study visits. - are in good health as determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations in the opinion of the investigator. - screening laboratory bloods - white blood cells (wbc), hemoglobin (hgb), platelets (plts), alanine aminotransferase (alt), total bilirubin (t. bili), aspartate aminotransferase (ast), gamma-glutamyl transferase (ggt), and creatinine (cr)) are within acceptable parameters as determined by the investigator - women of childbearing potential must use an acceptable contraception method and must have a negative urine or serum pregnancy test within 24 hours prior to the first study vaccination. exclusion criteria - have an acute illness, as determined by the site principal investigator (pi) or appropriate sub-investigator, within 72 hours prior to study vaccination. - have any medical disease or condition that, in the opinion of the site pi or appropriate sub-investigator, is a contraindication to study participation. *including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. - have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy. - use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination. - have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. non-melanoma, treated, skin cancers are permitted. - have known human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection. - have known hypersensitivity or allergy to insect stings or other components of the study vaccine. - have a history of severe reactions following previous immunization with licensed or unlicensed vaccines. - have a history of guillain-barré syndrome. - have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination. - have a history of potentially immune-mediated medical conditions (pimmcs). - have a history of alcohol or drug abuse within 5 years prior to study vaccination. - have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations as determined by the site pi or appropriate sub-investigator. - have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination. - have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination. - have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. - have a known history of documented covid-19 infection within the past 6 months. - received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period. - female participants who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination. - any participant whose enrolment, in the opinion of the investigator, would be detrimental to the participant or the study.