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

* known hypersensitivity or allergy to (components of) the vpm1002 vaccine or serious adverse reactions to prior bcg administration * known active or latent mycobacterium tuberculosis infection or with another mycobacterial species. a history with or suspicion of m. tuberculosis infection. * fever (\>38 °c) within the past 24 hours * pregnant or breast-feeding * suspicion of active viral or bacterial infection * participation of subject in another study within 30 days before screening and during this study * person is an employee of the sponsor, a relative of the investigator or in direct reporting line to clinical trial staff at the clinical trial site * severely immunocompromised subjects, such as: 1. subjects with known infection with the human immunodeficiency virus (hiv); 2. subjects with solid organ transplantation; 3. subjects with bone marrow transplantation; 4. subjects under chemotherapy, immunotherapy and radiotherapy; 5. subjects with primary immunodeficiency; 6. treatment with any anti-cytokine therapies; 7. treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months * active solid or non-solid malignancy or lymphoma in the past 5 years * direct involvement in the design or the execution of the present clinical trial * expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc) * employed to the hospital \< 22 hours per week * previous positive sars-cov-2 test result

* known hypersensitivity or allergy to (components of) the vpm1002 vaccine or serious adverse reactions to prior bcg administration * known active or latent mycobacterium tuberculosis infection or with another mycobacterial species. a history with or suspicion of m. tuberculosis infection. * fever (\>38 °c) within the past 24 hours * pregnant or breast-feeding * suspicion of active viral or bacterial infection * participation of subject in another study within 30 days before screening and during this study * person is an employee of the sponsor, a relative of the investigator or in direct reporting line to clinical trial staff at the clinical trial site * severely immunocompromised subjects, such as: 1. subjects with known infection with the human immunodeficiency virus (hiv); 2. subjects with solid organ transplantation; 3. subjects with bone marrow transplantation; 4. subjects under chemotherapy, immunotherapy and radiotherapy; 5. subjects with primary immunodeficiency; 6. treatment with any anti-cytokine therapies; 7. treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months * active solid or non-solid malignancy or lymphoma in the past 5 years * direct involvement in the design or the execution of the present clinical trial * expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc) * employed to the hospital \< 22 hours per week * previous positive sars-cov-2 test result

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

known hypersensitivity or allergy to (components of) the vpm1002 vaccine or serious adverse reactions to prior bcg administration known active or latent mycobacterium tuberculosis infection or with another mycobacterial species. a history with or suspicion of m. tuberculosis infection. fever (>38 °c) within the past 24 hours pregnant or breast-feeding suspicion of active viral or bacterial infection participation of subject in another study within 30 days before screening and during this study person is an employee of the sponsor, a relative of the investigator or in direct reporting line to clinical trial staff at the clinical trial site severely immunocompromised subjects, such as: subjects with known infection with the human immunodeficiency virus (hiv); subjects with solid organ transplantation; subjects with bone marrow transplantation; subjects under chemotherapy, immunotherapy and radiotherapy; subjects with primary immunodeficiency; treatment with any anti-cytokine therapies; treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months active solid or non-solid malignancy or lymphoma in the past 5 years direct involvement in the design or the execution of the present clinical trial expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc) employed to the hospital < 22 hours per week previous positive sars-cov-2 test result

known hypersensitivity or allergy to (components of) the vpm1002 vaccine or serious adverse reactions to prior bcg administration known active or latent mycobacterium tuberculosis infection or with another mycobacterial species. a history with or suspicion of m. tuberculosis infection. fever (>38 °c) within the past 24 hours pregnant or breast-feeding suspicion of active viral or bacterial infection participation of subject in another study within 30 days before screening and during this study person is an employee of the sponsor, a relative of the investigator or in direct reporting line to clinical trial staff at the clinical trial site severely immunocompromised subjects, such as: subjects with known infection with the human immunodeficiency virus (hiv); subjects with solid organ transplantation; subjects with bone marrow transplantation; subjects under chemotherapy, immunotherapy and radiotherapy; subjects with primary immunodeficiency; treatment with any anti-cytokine therapies; treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months active solid or non-solid malignancy or lymphoma in the past 5 years direct involvement in the design or the execution of the present clinical trial expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc) employed to the hospital < 22 hours per week previous positive sars-cov-2 test result

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

- known hypersensitivity or allergy to (components of) the vpm1002 vaccine or serious adverse reactions to prior bcg administration - known active or latent mycobacterium tuberculosis infection or with another mycobacterial species. a history with or suspicion of m. tuberculosis infection. - fever (>38 °c) within the past 24 hours - pregnant or breast-feeding - suspicion of active viral or bacterial infection - participation of subject in another study within 30 days before screening and during this study - person is an employee of the sponsor, a relative of the investigator or in direct reporting line to clinical trial staff at the clinical trial site - severely immunocompromised subjects, such as: 1. subjects with known infection with the human immunodeficiency virus (hiv); 2. subjects with solid organ transplantation; 3. subjects with bone marrow transplantation; 4. subjects under chemotherapy, immunotherapy and radiotherapy; 5. subjects with primary immunodeficiency; 6. treatment with any anti-cytokine therapies; 7. treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months - active solid or non-solid malignancy or lymphoma in the past 5 years - direct involvement in the design or the execution of the present clinical trial - expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc) - employed to the hospital < 22 hours per week - previous positive sars-cov-2 test result

- known hypersensitivity or allergy to (components of) the vpm1002 vaccine or serious adverse reactions to prior bcg administration - known active or latent mycobacterium tuberculosis infection or with another mycobacterial species. a history with or suspicion of m. tuberculosis infection. - fever (>38 °c) within the past 24 hours - pregnant or breast-feeding - suspicion of active viral or bacterial infection - participation of subject in another study within 30 days before screening and during this study - person is an employee of the sponsor, a relative of the investigator or in direct reporting line to clinical trial staff at the clinical trial site - severely immunocompromised subjects, such as: 1. subjects with known infection with the human immunodeficiency virus (hiv); 2. subjects with solid organ transplantation; 3. subjects with bone marrow transplantation; 4. subjects under chemotherapy, immunotherapy and radiotherapy; 5. subjects with primary immunodeficiency; 6. treatment with any anti-cytokine therapies; 7. treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months - active solid or non-solid malignancy or lymphoma in the past 5 years - direct involvement in the design or the execution of the present clinical trial - expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc) - employed to the hospital < 22 hours per week - previous positive sars-cov-2 test result