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

1.History of vaccination with any investigational or approved vaccine against COVID-19 disease. <br/ >2.Subject living in the same household as that of any active COVID-19 positive individual at the time of enrolment. <br/ >3.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/ >4.Subjects with any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator. <br/ >5.Subjects with Body temperature of �100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination. <br/ >6.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study. <br/ >7.Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study: <br/ >i.severe psychiatric conditions, <br/ >ii.any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >iii.allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE CORBEVAX vaccine), <br/ >iv.neurological illness, and any other serious chronic illness requiring hospital specialist supervision. <br/ >8.Subjects requiring 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. <br/ >i.For corticosteroids, this will mean prednisone �0.5 mg/kg/day, or equivalent. <br/ >ii.Inhaled and topical steroids are allowed. <br/ >iii.Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data. <br/ >9.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). <br/ >10.Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >11.Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment. <br/ >12.Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >13.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 or approved vaccine against COVID-19 disease. <br/ >2.Subject living in the same household as that of any active COVID-19 positive individual at the time of enrolment. <br/ >3.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/ >4.Subjects with any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator. <br/ >5.Subjects with Body temperature of �100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination. <br/ >6.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study. <br/ >7.Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study: <br/ >i.severe psychiatric conditions, <br/ >ii.any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >iii.allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE CORBEVAX vaccine), <br/ >iv.neurological illness, and any other serious chronic illness requiring hospital specialist supervision. <br/ >8.Subjects requiring 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. <br/ >i.For corticosteroids, this will mean prednisone �0.5 mg/kg/day, or equivalent. <br/ >ii.Inhaled and topical steroids are allowed. <br/ >iii.Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data. <br/ >9.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). <br/ >10.Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >11.Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment. <br/ >12.Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >13.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

Sept. 8, 2021, 1:30 a.m. oms

1.History of vaccination with any investigational or approved vaccine against COVID-19 disease. <br/ >2.Subject living in the same household as that of any active COVID-19 positive individual at the time of enrolment. <br/ >3.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/ >4.Subjects with any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator. <br/ >5.Subjects with Body temperature of �100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination. <br/ >6.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study. <br/ >7.Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study: <br/ >i.severe psychiatric conditions, <br/ >ii.any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >iii.allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE CORBEVAX vaccine), <br/ >iv.neurological illness, and any other serious chronic illness requiring hospital specialist supervision. <br/ >8.Subjects requiring 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. <br/ >i.For corticosteroids, this will mean prednisone �0.5 mg/kg/day, or equivalent. <br/ >ii.Inhaled and topical steroids are allowed. <br/ >iii.Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data. <br/ >9.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). <br/ >10.Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >11.Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment. <br/ >12.Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >13.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 or approved vaccine against COVID-19 disease. <br/ >2.Subject living in the same household as that of any active COVID-19 positive individual at the time of enrolment. <br/ >3.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/ >4.Subjects with any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator. <br/ >5.Subjects with Body temperature of �100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination. <br/ >6.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study. <br/ >7.Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study: <br/ >i.severe psychiatric conditions, <br/ >ii.any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >iii.allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE CORBEVAX vaccine), <br/ >iv.neurological illness, and any other serious chronic illness requiring hospital specialist supervision. <br/ >8.Subjects requiring 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. <br/ >i.For corticosteroids, this will mean prednisone �0.5 mg/kg/day, or equivalent. <br/ >ii.Inhaled and topical steroids are allowed. <br/ >iii.Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data. <br/ >9.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). <br/ >10.Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >11.Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment. <br/ >12.Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >13.Individuals who are part of the study team or close family members of individuals conducting the study. <br/ >