| Trial registration number
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DRKS00027372 |
Full text link
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.drks.de/DRKS00027372
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First author
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Haifa Kathrin Al-Ali
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Contact
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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haifa.al-ali@uk-halle.de
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Registration date
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-01-11
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Recruitment status
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
patients• age = 18 years• one of the following malignant diagnoses:- myeloid disorders (AML, MPN, or MDS)- lymphatic disorders (CLL, lymphoma, or MM)- malignant diseases treated with checkpoint inhibitorshealthy subjects• age = 18 Jahre• willingness to or present appointment for covid-19 vaccination
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Exclusion criteria
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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patients• patients not willing to or unable to get vaccinated• patients with a duration of remission of = 5 years• patients unable to give consenthealthy subjects• subjects not willing to or unable to get vaccinated according to recommendations of the Robert-Koch-Institut• subjects with a malignant disease and a duration of remission of < 5 years• subjects unable to give consent
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Number of arms
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Krukenberg Krebszentrum Halle
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Inclusion age min
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Germany
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Type of patients
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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High risk patients
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Severity scale
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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417
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primary outcome
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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humoral immune response to the covid-19 vaccine of patients with hemato-oncological diseases compared to healthy subjects on day 35 (+7) after initial vaccination
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Notes
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "hemato-oncological patientsBlood samples before and after vaccination (day 35 and day 120 after the first vaccination) of patients and healthy controls; who decided to be vaccinated close to home according to the recommendation of the Robert Koch Institute; will be examined for a corresponding immune reaction.", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "healthy subjects", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}]
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