Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1.History of vaccination with any investigational vaccine against COVID-19 disease, <br/ >2.Seropositive to IgG antibodies against SARS CoV-2 <br/ >3.Living in the same household of any COVID-19 positive person, <br/ >4.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during clinical trials, <br/ >5.Seriously overweight (BMI â?¥ 40 Kg/m2), <br/ >6.Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment, <br/ >7.History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines), <br/ >8.Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >9.Any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator, <br/ >10.Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination, <br/ >11.History of severe psychiatric conditions likely to affect participation in the study, <br/ >12.History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >13.History of allergic disease or reactions likely to be exacerbated by any component of the Biological Eâ??s four COVID-19 vaccine formulations, <br/ >14.Chronic respiratory diseases, including asthma, <br/ >15.Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness, <br/ >16.Any other serious chronic illness requiring hospital specialist supervision, <br/ >17.Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week for at least one year, <br/ >18.Chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. For corticosteroids, this will mean prednisone â?¥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed, <br/ >19.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), <br/ >20.Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >21.Individuals who are part of the study team or close family members of individuals conducting the study. <br/ >

1.History of vaccination with any investigational vaccine against COVID-19 disease, <br/ >2.Seropositive to IgG antibodies against SARS CoV-2 <br/ >3.Living in the same household of any COVID-19 positive person, <br/ >4.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during clinical trials, <br/ >5.Seriously overweight (BMI â?¥ 40 Kg/m2), <br/ >6.Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment, <br/ >7.History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines), <br/ >8.Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >9.Any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator, <br/ >10.Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination, <br/ >11.History of severe psychiatric conditions likely to affect participation in the study, <br/ >12.History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >13.History of allergic disease or reactions likely to be exacerbated by any component of the Biological Eâ??s four COVID-19 vaccine formulations, <br/ >14.Chronic respiratory diseases, including asthma, <br/ >15.Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness, <br/ >16.Any other serious chronic illness requiring hospital specialist supervision, <br/ >17.Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week for at least one year, <br/ >18.Chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. For corticosteroids, this will mean prednisone â?¥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed, <br/ >19.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), <br/ >20.Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >21.Individuals who are part of the study team or close family members of individuals conducting the study. <br/ >

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

Dec. 5, 2020, 12:45 a.m. oms

1.History of vaccination with any investigational vaccine against COVID-19 disease, <br/ >2.Seropositive to IgG antibodies against SARS CoV-2 <br/ >3.Living in the same household of any COVID-19 positive person, <br/ >4.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during clinical trials, <br/ >5.Seriously overweight (BMI â?¥ 40 Kg/m2), <br/ >6.Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment, <br/ >7.History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines), <br/ >8.Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >9.Any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator, <br/ >10.Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination, <br/ >11.History of severe psychiatric conditions likely to affect participation in the study, <br/ >12.History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >13.History of allergic disease or reactions likely to be exacerbated by any component of the Biological Eâ??s four COVID-19 vaccine formulations, <br/ >14.Chronic respiratory diseases, including asthma, <br/ >15.Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness, <br/ >16.Any other serious chronic illness requiring hospital specialist supervision, <br/ >17.Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week for at least one year, <br/ >18.Chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. For corticosteroids, this will mean prednisone â?¥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed, <br/ >19.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), <br/ >20.Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >21.Individuals who are part of the study team or close family members of individuals conducting the study. <br/ >

1.History of vaccination with any investigational vaccine against COVID-19 disease, <br/ >2.Seropositive to IgG antibodies against SARS CoV-2 <br/ >3.Living in the same household of any COVID-19 positive person, <br/ >4.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during clinical trials, <br/ >5.Seriously overweight (BMI â?¥ 40 Kg/m2), <br/ >6.Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment, <br/ >7.History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines), <br/ >8.Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >9.Any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator, <br/ >10.Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination, <br/ >11.History of severe psychiatric conditions likely to affect participation in the study, <br/ >12.History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >13.History of allergic disease or reactions likely to be exacerbated by any component of the Biological Eâ??s four COVID-19 vaccine formulations, <br/ >14.Chronic respiratory diseases, including asthma, <br/ >15.Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness, <br/ >16.Any other serious chronic illness requiring hospital specialist supervision, <br/ >17.Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week for at least one year, <br/ >18.Chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. For corticosteroids, this will mean prednisone â?¥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed, <br/ >19.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), <br/ >20.Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >21.Individuals who are part of the study team or close family members of individuals conducting the study. <br/ >