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

inclusion criteria: 1. adult (≥18 years) male or non-pregnant, non-lactating female 2. primary antibody deficiency syndrome or secondary antibody deficiency syndrome, defined by one of the following: * igg \< 4 g/l * ongoing substitution of immunoglobline for hypogammaglobinemia * anti-cd20 antibody (monospecific) therapy for malignant disease: * after combined anti-cd20 antibody therapy with chemotherapy (e.g. fludarabin, cyclophosphamid, bendamustin, anthracycline, vincristin) or btk-inhibitors or bcl2-inhibitors (within 1-6 months post therapy) * ongoing single agent anti-cd20 antibody therapy * anti-cd20 antibody maintenance therapy 3. ability to understand and voluntarily sign an informed consent form 4. ability to adhere to the study visit schedule and other protocol requirements 5. female patients of child bearing potential (fcbp) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception. this should be started from the signing of the informed consent and continue until three months after vaccination. furthermore, contraception must be carried on by patients receiving b-cell depleting therapies for the whole duration of the treatment. 6. postmenopausal or evidence of non-child-bearing status. for women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to study treatment. postmenopausal or evidence of nonchildbearing status is defined as: * amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments * luteinizing hormone (lh) and follicle stimulating hormone (fsh) levels in the postmenopausal range for women under 50

inclusion criteria: 1. adult (≥18 years) male or non-pregnant, non-lactating female 2. primary antibody deficiency syndrome or secondary antibody deficiency syndrome, defined by one of the following: * igg \< 4 g/l * ongoing substitution of immunoglobline for hypogammaglobinemia * anti-cd20 antibody (monospecific) therapy for malignant disease: * after combined anti-cd20 antibody therapy with chemotherapy (e.g. fludarabin, cyclophosphamid, bendamustin, anthracycline, vincristin) or btk-inhibitors or bcl2-inhibitors (within 1-6 months post therapy) * ongoing single agent anti-cd20 antibody therapy * anti-cd20 antibody maintenance therapy 3. ability to understand and voluntarily sign an informed consent form 4. ability to adhere to the study visit schedule and other protocol requirements 5. female patients of child bearing potential (fcbp) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception. this should be started from the signing of the informed consent and continue until three months after vaccination. furthermore, contraception must be carried on by patients receiving b-cell depleting therapies for the whole duration of the treatment. 6. postmenopausal or evidence of non-child-bearing status. for women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to study treatment. postmenopausal or evidence of nonchildbearing status is defined as: * amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments * luteinizing hormone (lh) and follicle stimulating hormone (fsh) levels in the postmenopausal range for women under 50

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

inclusion criteria: adult (≥18 years) male or non-pregnant, non-lactating female primary antibody deficiency syndrome or secondary antibody deficiency syndrome, defined by one of the following: igg < 4 g/l ongoing substitution of immunoglobline for hypogammaglobinemia anti-cd20 antibody (monospecific) therapy for malignant disease: after combined anti-cd20 antibody therapy with chemotherapy (e.g. fludarabin, cyclophosphamid, bendamustin, anthracycline, vincristin) or btk-inhibitors or bcl2-inhibitors (within 1-6 months post therapy) ongoing single agent anti-cd20 antibody therapy anti-cd20 antibody maintenance therapy ability to understand and voluntarily sign an informed consent form ability to adhere to the study visit schedule and other protocol requirements female patients of child bearing potential (fcbp) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception. this should be started from the signing of the informed consent and continue until three months after vaccination. furthermore, contraception must be carried on by patients receiving b-cell depleting therapies for the whole duration of the treatment. postmenopausal or evidence of non-child-bearing status. for women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to study treatment. postmenopausal or evidence of nonchildbearing status is defined as: amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments luteinizing hormone (lh) and follicle stimulating hormone (fsh) levels in the postmenopausal range for women under 50

inclusion criteria: adult (≥18 years) male or non-pregnant, non-lactating female primary antibody deficiency syndrome or secondary antibody deficiency syndrome, defined by one of the following: igg < 4 g/l ongoing substitution of immunoglobline for hypogammaglobinemia anti-cd20 antibody (monospecific) therapy for malignant disease: after combined anti-cd20 antibody therapy with chemotherapy (e.g. fludarabin, cyclophosphamid, bendamustin, anthracycline, vincristin) or btk-inhibitors or bcl2-inhibitors (within 1-6 months post therapy) ongoing single agent anti-cd20 antibody therapy anti-cd20 antibody maintenance therapy ability to understand and voluntarily sign an informed consent form ability to adhere to the study visit schedule and other protocol requirements female patients of child bearing potential (fcbp) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception. this should be started from the signing of the informed consent and continue until three months after vaccination. furthermore, contraception must be carried on by patients receiving b-cell depleting therapies for the whole duration of the treatment. postmenopausal or evidence of non-child-bearing status. for women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to study treatment. postmenopausal or evidence of nonchildbearing status is defined as: amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments luteinizing hormone (lh) and follicle stimulating hormone (fsh) levels in the postmenopausal range for women under 50

July 14, 2021, 6 a.m. usa

inclusion criteria: 1. adult (≥18 years) male or non-pregnant, non-lactating female 2. primary antibody deficiency syndrome or secondary antibody deficiency syndrome, defined by one of the following: - igg < 4 g/l - ongoing substitution of immunoglobline for hypogammaglobinemia - anti-cd20 antibody (monospecific) therapy for malignant disease: - after combined anti-cd20 antibody therapy with chemotherapy (e.g. fludarabin, cyclophosphamid, bendamustin, anthracycline, vincristin) or btk-inhibitors or bcl2-inhibitors (within 1-6 months post therapy) - ongoing single agent anti-cd20 antibody therapy - anti-cd20 antibody maintenance therapy 3. ability to understand and voluntarily sign an informed consent form 4. ability to adhere to the study visit schedule and other protocol requirements 5. female patients of child bearing potential (fcbp) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception. this should be started from the signing of the informed consent and continue until three months after vaccination. furthermore, contraception must be carried on by patients receiving b-cell depleting therapies for the whole duration of the treatment. 6. postmenopausal or evidence of non-child-bearing status. for women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to study treatment. postmenopausal or evidence of nonchildbearing status is defined as: - amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments - luteinizing hormone (lh) and follicle stimulating hormone (fsh) levels in the postmenopausal range for women under 50

inclusion criteria: 1. adult (≥18 years) male or non-pregnant, non-lactating female 2. primary antibody deficiency syndrome or secondary antibody deficiency syndrome, defined by one of the following: - igg < 4 g/l - ongoing substitution of immunoglobline for hypogammaglobinemia - anti-cd20 antibody (monospecific) therapy for malignant disease: - after combined anti-cd20 antibody therapy with chemotherapy (e.g. fludarabin, cyclophosphamid, bendamustin, anthracycline, vincristin) or btk-inhibitors or bcl2-inhibitors (within 1-6 months post therapy) - ongoing single agent anti-cd20 antibody therapy - anti-cd20 antibody maintenance therapy 3. ability to understand and voluntarily sign an informed consent form 4. ability to adhere to the study visit schedule and other protocol requirements 5. female patients of child bearing potential (fcbp) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception. this should be started from the signing of the informed consent and continue until three months after vaccination. furthermore, contraception must be carried on by patients receiving b-cell depleting therapies for the whole duration of the treatment. 6. postmenopausal or evidence of non-child-bearing status. for women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to study treatment. postmenopausal or evidence of nonchildbearing status is defined as: - amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments - luteinizing hormone (lh) and follicle stimulating hormone (fsh) levels in the postmenopausal range for women under 50