Created at Source Raw Value Validated value
Feb. 12, 2021, 1:30 a.m. eu

CLL patients 1. Patients receiving high dose corticosteroids ( ≥20 mg Prednisolone) or other immunosuppressive drugs that is not part of active CLL treatment 2. Patients who have had an allergic reaction to any vaccination in the past 3. Patients with a positive DAT (Direct Antiglobulin Test) or known present or previous hemolysis, ITP and Guillain-Barre 4. Patients failing to give informed consent 5. Patients with ongoing immunoglobulin therapy 6. Patients with known HIV infection 7. Patients who have received a pneumococcal vaccine outside the study protocol within the last 12 months 8. Active febrile infection 9. Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection Controls 1. Serious chronic disorder including chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen treatment, end-stage renal disease, clinically unstable cardiac disease or any other disorder that, in the investigator’s opinion, excludes the subject from participating in the study, 2. Known or suspected immunodeficiency or other conditions associated with immunosuppression including immunoglobulin class/subclass deficiencies with or without substitution treatment, splenectomy in the medical history, generalized malignancy, human immunodeficiency virus (HIV) infection, haematological malignancies, bone marrow or organ transplant in the medical history, 3. Subjects receiving treatment with high dose corticosteroids (≥20 mg Prednisolone) or other immunosuppressive drugs, or planned to receive through study participation, 4. Subjects who have had an allergic reaction to any component of PCV13 in the past, 5. Subjects with known present or previous hemolysis, ITP and Guillain-Barre, 6. Subjects failing to give informed consent, 7. Subjects who have received a pneumococcal vaccine after the primary vaccination aproximately 3-5 years ago, 8. Active febrile infection, 1.9. Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection (for treatment with oral anticoagulation therapy, see section 7.3).

CLL patients 1. Patients receiving high dose corticosteroids ( ≥20 mg Prednisolone) or other immunosuppressive drugs that is not part of active CLL treatment 2. Patients who have had an allergic reaction to any vaccination in the past 3. Patients with a positive DAT (Direct Antiglobulin Test) or known present or previous hemolysis, ITP and Guillain-Barre 4. Patients failing to give informed consent 5. Patients with ongoing immunoglobulin therapy 6. Patients with known HIV infection 7. Patients who have received a pneumococcal vaccine outside the study protocol within the last 12 months 8. Active febrile infection 9. Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection Controls 1. Serious chronic disorder including chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen treatment, end-stage renal disease, clinically unstable cardiac disease or any other disorder that, in the investigator’s opinion, excludes the subject from participating in the study, 2. Known or suspected immunodeficiency or other conditions associated with immunosuppression including immunoglobulin class/subclass deficiencies with or without substitution treatment, splenectomy in the medical history, generalized malignancy, human immunodeficiency virus (HIV) infection, haematological malignancies, bone marrow or organ transplant in the medical history, 3. Subjects receiving treatment with high dose corticosteroids (≥20 mg Prednisolone) or other immunosuppressive drugs, or planned to receive through study participation, 4. Subjects who have had an allergic reaction to any component of PCV13 in the past, 5. Subjects with known present or previous hemolysis, ITP and Guillain-Barre, 6. Subjects failing to give informed consent, 7. Subjects who have received a pneumococcal vaccine after the primary vaccination aproximately 3-5 years ago, 8. Active febrile infection, 1.9. Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection (for treatment with oral anticoagulation therapy, see section 7.3).