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

* prior intravesical bcg or intradermal bcg, with the exception of tuberculosis vaccination in childhood. * previous known history of latent or active tuberculosis * known kidney, liver or blood disorders which impairs organ and marrow function * chronic administration of steroids (\>10 mg prednisone) at the time of randomization * current or planned concomitant biologic therapy in the next 7 months. * known hypersensitivity or allergy to components of vpm1002 * pregnant or planning to become pregnant in the future 7 months. * breastfeeding. * current suspected viral or bacterial infection. * body temperature \> 38° c * participation in another interventional study with potentially conflicting medication within 30 days before screening. * the presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy (e.g., anti-tnf therapy, methotrexate, azathioprine, antimalarials). * active malignancy requiring treatment. * known positive hiv serology. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to bcg vaccine. * previous positive covid-19 confirmed infection. * uncontrolled intercurrent illness. * psychiatric illness/social situations that would limit compliance with study requirements.

* prior intravesical bcg or intradermal bcg, with the exception of tuberculosis vaccination in childhood. * previous known history of latent or active tuberculosis * known kidney, liver or blood disorders which impairs organ and marrow function * chronic administration of steroids (\>10 mg prednisone) at the time of randomization * current or planned concomitant biologic therapy in the next 7 months. * known hypersensitivity or allergy to components of vpm1002 * pregnant or planning to become pregnant in the future 7 months. * breastfeeding. * current suspected viral or bacterial infection. * body temperature \> 38° c * participation in another interventional study with potentially conflicting medication within 30 days before screening. * the presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy (e.g., anti-tnf therapy, methotrexate, azathioprine, antimalarials). * active malignancy requiring treatment. * known positive hiv serology. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to bcg vaccine. * previous positive covid-19 confirmed infection. * uncontrolled intercurrent illness. * psychiatric illness/social situations that would limit compliance with study requirements.

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

- prior intravesical bcg or intradermal bcg, with the exception of tuberculosis vaccination in childhood. - previous known history of latent or active tuberculosis - known kidney, liver or blood disorders which impairs organ and marrow function - chronic administration of steroids (>10 mg prednisone) at the time of randomization - current or planned concomitant biologic therapy in the next 7 months. - known hypersensitivity or allergy to components of vpm1002 - pregnant or planning to become pregnant in the future 7 months. - breastfeeding. - current suspected viral or bacterial infection. - body temperature > 38° c - participation in another interventional study with potentially conflicting medication within 30 days before screening. - the presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy (e.g., anti-tnf therapy, methotrexate, azathioprine, antimalarials). - active malignancy requiring treatment. - known positive hiv serology. - history of allergic reactions attributed to compounds of similar chemical or biologic composition to bcg vaccine. - previous positive covid-19 confirmed infection. - uncontrolled intercurrent illness. - psychiatric illness/social situations that would limit compliance with study requirements.

- prior intravesical bcg or intradermal bcg, with the exception of tuberculosis vaccination in childhood. - previous known history of latent or active tuberculosis - known kidney, liver or blood disorders which impairs organ and marrow function - chronic administration of steroids (>10 mg prednisone) at the time of randomization - current or planned concomitant biologic therapy in the next 7 months. - known hypersensitivity or allergy to components of vpm1002 - pregnant or planning to become pregnant in the future 7 months. - breastfeeding. - current suspected viral or bacterial infection. - body temperature > 38° c - participation in another interventional study with potentially conflicting medication within 30 days before screening. - the presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy (e.g., anti-tnf therapy, methotrexate, azathioprine, antimalarials). - active malignancy requiring treatment. - known positive hiv serology. - history of allergic reactions attributed to compounds of similar chemical or biologic composition to bcg vaccine. - previous positive covid-19 confirmed infection. - uncontrolled intercurrent illness. - psychiatric illness/social situations that would limit compliance with study requirements.