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

* history of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. * female who is pregnant or positive in pregnancy test at screening or just prior to vaccination administration or plans to become pregnant from the time of study vaccination through 30 days after the administration of the study vaccine. * female who is breast-feeding or plans to breastfeed from the time of the study vaccination through 30 days after the administration of the study vaccine. * investigational non-coronavirus vaccines: previous receipt of an investigational vaccine (non-coronavirus) within 1 year before the planned administration of study vaccine. * prior administration of attenuated, nucleic acid (mrna or dna) or vectored vaccines in last 1 month before the study vaccine or expectation of such vaccines in the month after the study vaccine. * prior administration of subunit vaccine or inactivated vaccine in last 14 days before the study vaccine or expectation of receipt of such vaccines in the 14 days after the study vaccine. * judged by the investigator on the basis of evidence or medical history, immunosuppressive or immunodeficient state, autoimmune diseases, chronic kidney disease (with dialysis), asplenia, or recurrent severe infections. * prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before the study vaccination. * receipt of short-term systemic corticosteroids. study intervention administration should be delayed until systemic corticosteroid use has been discontinued for at least 28 days. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. * has received systemic immunoglobulins or blood products within 4 months prior to enrollment. * loss or donation of blood over 500 ml within 3 months prior to screening visit or intention to donate blood or blood products for transfusion during the study. * participants who received specific anti-sars-cov-2 monoclonal antibody products at any time. * subjects who take part in another clinical study and are currently receiving or received any investigational intervention within 12 weeks prior to the day of informed consent. * platelet disorder or other bleeding disorder may cause injection contraindication. * any acute illness, as determined by the study investigator 3 days before vaccination. * judged by the investigator on the basis of evidence or medical history, participants with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies) will be excluded. * history of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ. * known history of sars, mers or sars-cov-2 infection. * alcoholism or substance abuser. * behavioral, cognitive, or psychiatric disease that, in the opinion of investigators, affects the participant's ability to understand and cooperate with all study protocol requirements. * employees at the investigator's site, of the sponsor or the contract research organization (cro) directly involved in the conduct of the study.

* history of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. * female who is pregnant or positive in pregnancy test at screening or just prior to vaccination administration or plans to become pregnant from the time of study vaccination through 30 days after the administration of the study vaccine. * female who is breast-feeding or plans to breastfeed from the time of the study vaccination through 30 days after the administration of the study vaccine. * investigational non-coronavirus vaccines: previous receipt of an investigational vaccine (non-coronavirus) within 1 year before the planned administration of study vaccine. * prior administration of attenuated, nucleic acid (mrna or dna) or vectored vaccines in last 1 month before the study vaccine or expectation of such vaccines in the month after the study vaccine. * prior administration of subunit vaccine or inactivated vaccine in last 14 days before the study vaccine or expectation of receipt of such vaccines in the 14 days after the study vaccine. * judged by the investigator on the basis of evidence or medical history, immunosuppressive or immunodeficient state, autoimmune diseases, chronic kidney disease (with dialysis), asplenia, or recurrent severe infections. * prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before the study vaccination. * receipt of short-term systemic corticosteroids. study intervention administration should be delayed until systemic corticosteroid use has been discontinued for at least 28 days. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. * has received systemic immunoglobulins or blood products within 4 months prior to enrollment. * loss or donation of blood over 500 ml within 3 months prior to screening visit or intention to donate blood or blood products for transfusion during the study. * participants who received specific anti-sars-cov-2 monoclonal antibody products at any time. * subjects who take part in another clinical study and are currently receiving or received any investigational intervention within 12 weeks prior to the day of informed consent. * platelet disorder or other bleeding disorder may cause injection contraindication. * any acute illness, as determined by the study investigator 3 days before vaccination. * judged by the investigator on the basis of evidence or medical history, participants with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies) will be excluded. * history of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ. * known history of sars, mers or sars-cov-2 infection. * alcoholism or substance abuser. * behavioral, cognitive, or psychiatric disease that, in the opinion of investigators, affects the participant's ability to understand and cooperate with all study protocol requirements. * employees at the investigator's site, of the sponsor or the contract research organization (cro) directly involved in the conduct of the study.

Feb. 16, 2022, 4:30 p.m. usa

history of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. female who is pregnant or positive in pregnancy test at screening or just prior to vaccination administration or plans to become pregnant from the time of study vaccination through 30 days after the administration of the study vaccine. female who is breast-feeding or plans to breastfeed from the time of the study vaccination through 30 days after the administration of the study vaccine. investigational non-coronavirus vaccines: previous receipt of an investigational vaccine (non-coronavirus) within 1 year before the planned administration of study vaccine. prior administration of attenuated, nucleic acid (mrna or dna) or vectored vaccines in last 1 month before the study vaccine or expectation of such vaccines in the month after the study vaccine. prior administration of subunit vaccine or inactivated vaccine in last 14 days before the study vaccine or expectation of receipt of such vaccines in the 14 days after the study vaccine. judged by the investigator on the basis of evidence or medical history, immunosuppressive or immunodeficient state, autoimmune diseases, chronic kidney disease (with dialysis), asplenia, or recurrent severe infections. prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before the study vaccination. receipt of short-term systemic corticosteroids. study intervention administration should be delayed until systemic corticosteroid use has been discontinued for at least 28 days. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. has received systemic immunoglobulins or blood products within 4 months prior to enrollment. loss or donation of blood over 500 ml within 3 months prior to screening visit or intention to donate blood or blood products for transfusion during the study. participants who received specific anti-sars-cov-2 monoclonal antibody products at any time. subjects who take part in another clinical study and are currently receiving or received any investigational intervention within 12 weeks prior to the day of informed consent. platelet disorder or other bleeding disorder may cause injection contraindication. any acute illness, as determined by the study investigator 3 days before vaccination. judged by the investigator on the basis of evidence or medical history, participants with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies) will be excluded. history of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ. known history of sars, mers or sars-cov-2 infection. alcoholism or substance abuser. behavioral, cognitive, or psychiatric disease that, in the opinion of investigators, affects the participant's ability to understand and cooperate with all study protocol requirements. employees at the investigator's site, of the sponsor or the contract research organization (cro) directly involved in the conduct of the study.

history of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. female who is pregnant or positive in pregnancy test at screening or just prior to vaccination administration or plans to become pregnant from the time of study vaccination through 30 days after the administration of the study vaccine. female who is breast-feeding or plans to breastfeed from the time of the study vaccination through 30 days after the administration of the study vaccine. investigational non-coronavirus vaccines: previous receipt of an investigational vaccine (non-coronavirus) within 1 year before the planned administration of study vaccine. prior administration of attenuated, nucleic acid (mrna or dna) or vectored vaccines in last 1 month before the study vaccine or expectation of such vaccines in the month after the study vaccine. prior administration of subunit vaccine or inactivated vaccine in last 14 days before the study vaccine or expectation of receipt of such vaccines in the 14 days after the study vaccine. judged by the investigator on the basis of evidence or medical history, immunosuppressive or immunodeficient state, autoimmune diseases, chronic kidney disease (with dialysis), asplenia, or recurrent severe infections. prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before the study vaccination. receipt of short-term systemic corticosteroids. study intervention administration should be delayed until systemic corticosteroid use has been discontinued for at least 28 days. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. has received systemic immunoglobulins or blood products within 4 months prior to enrollment. loss or donation of blood over 500 ml within 3 months prior to screening visit or intention to donate blood or blood products for transfusion during the study. participants who received specific anti-sars-cov-2 monoclonal antibody products at any time. subjects who take part in another clinical study and are currently receiving or received any investigational intervention within 12 weeks prior to the day of informed consent. platelet disorder or other bleeding disorder may cause injection contraindication. any acute illness, as determined by the study investigator 3 days before vaccination. judged by the investigator on the basis of evidence or medical history, participants with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies) will be excluded. history of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ. known history of sars, mers or sars-cov-2 infection. alcoholism or substance abuser. behavioral, cognitive, or psychiatric disease that, in the opinion of investigators, affects the participant's ability to understand and cooperate with all study protocol requirements. employees at the investigator's site, of the sponsor or the contract research organization (cro) directly involved in the conduct of the study.

Dec. 30, 2021, 4:30 a.m. usa

history of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. female who is pregnant or positive in pregnancy test at screening or just prior to vaccination administration or plans to become pregnant from the time of study vaccination through 30 days after the administration of the study vaccine. female who is breast-feeding or plans to breastfeed from the time of the study vaccination through 30 days after the administration of the study vaccine. investigational non-coronavirus vaccines: previous receipt of an investigational vaccine (non-coronavirus) within 1 year before the planned administration of study vaccine. prior administration of attenuated, nucleic acid (mrna or dna) or vectored vaccines in last 1 month before the study vaccine or expectation of such vaccines in the month after the study vaccine. prior administration of subunit vaccine or inactivated vaccine in last 14 days before the study vaccine or expectation of receipt of such vaccines in the 14 days after the study vaccine. judged by the investigator on the basis of evidence or medical history, immunosuppressive or immunodeficient state, autoimmune diseases, chronic kidney disease (with dialysis), asplenia, or recurrent severe infections. prior chronic administration (defined as ≥ 14 day of continuous use) of immunosuppressant or corticosteroids (equivalent to ≥ 20 mg daily of prednisone), cytotoxic treatment in last 6 months before the study vaccination. receipt of short-term (<14 days) systemic corticosteroids. study intervention administration should be delayed until systemic corticosteroid use has been discontinued for at least 28 days. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. has received systemic immunoglobulins or blood products within 4 months prior to enrollment. loss or donation of blood over 500 ml within 3 months prior to screening visit or intention to donate blood or blood products for transfusion during the study. participants who received specific anti-sars-cov-2 monoclonal antibody products at any time. subjects who take part in another clinical study and are currently receiving or received any investigational intervention within 12 weeks prior to the day of informed consent. platelet disorder or other bleeding disorder may cause injection contraindication. any acute illness, as determined by the study investigator 3 days before vaccination. judged by the investigator on the basis of evidence or medical history, participants with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies) will be excluded. history of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ. known history of sars, mers or sars-cov-2 infection. alcoholism or substance abuser. behavioral, cognitive, or psychiatric disease that, in the opinion of investigators, affects the participant's ability to understand and cooperate with all study protocol requirements. employees at the investigator's site, of the sponsor or the contract research organization (cro) directly involved in the conduct of the study.

history of anaphylaxis, urticarial, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. female who is pregnant or positive in pregnancy test at screening or just prior to vaccination administration or plans to become pregnant from the time of study vaccination through 30 days after the administration of the study vaccine. female who is breast-feeding or plans to breastfeed from the time of the study vaccination through 30 days after the administration of the study vaccine. investigational non-coronavirus vaccines: previous receipt of an investigational vaccine (non-coronavirus) within 1 year before the planned administration of study vaccine. prior administration of attenuated, nucleic acid (mrna or dna) or vectored vaccines in last 1 month before the study vaccine or expectation of such vaccines in the month after the study vaccine. prior administration of subunit vaccine or inactivated vaccine in last 14 days before the study vaccine or expectation of receipt of such vaccines in the 14 days after the study vaccine. judged by the investigator on the basis of evidence or medical history, immunosuppressive or immunodeficient state, autoimmune diseases, chronic kidney disease (with dialysis), asplenia, or recurrent severe infections. prior chronic administration (defined as ≥ 14 day of continuous use) of immunosuppressant or corticosteroids (equivalent to ≥ 20 mg daily of prednisone), cytotoxic treatment in last 6 months before the study vaccination. receipt of short-term (<14 days) systemic corticosteroids. study intervention administration should be delayed until systemic corticosteroid use has been discontinued for at least 28 days. inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. has received systemic immunoglobulins or blood products within 4 months prior to enrollment. loss or donation of blood over 500 ml within 3 months prior to screening visit or intention to donate blood or blood products for transfusion during the study. participants who received specific anti-sars-cov-2 monoclonal antibody products at any time. subjects who take part in another clinical study and are currently receiving or received any investigational intervention within 12 weeks prior to the day of informed consent. platelet disorder or other bleeding disorder may cause injection contraindication. any acute illness, as determined by the study investigator 3 days before vaccination. judged by the investigator on the basis of evidence or medical history, participants with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies) will be excluded. history of malignancy within 5 years prior to screening visit, except basal cell carcinoma of the skin and cervical carcinoma in situ. known history of sars, mers or sars-cov-2 infection. alcoholism or substance abuser. behavioral, cognitive, or psychiatric disease that, in the opinion of investigators, affects the participant's ability to understand and cooperate with all study protocol requirements. employees at the investigator's site, of the sponsor or the contract research organization (cro) directly involved in the conduct of the study.