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ID
42646
Beschrijving
Evaluation of the Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084); ODM derived from: https://clinicaltrials.gov/show/NCT02135666
Link
https://clinicaltrials.gov/show/NCT02135666
Trefwoorden
Versies (2)
- 17-11-15 17-11-15 -
- 17-09-21 17-09-21 -
Geüploaded op
17 september 2021
DOI
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Licentie
Creative Commons BY-NC 3.0
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Eligibility Hepatitis B NCT02135666
Eligibility Hepatitis B NCT02135666
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT02135666
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Ability to comply with treatment
Item
subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
boolean
C0582783 (UMLS CUI [1])
Twinrix
Item
a male or female who received two/three doses of twinrix according to his/her group allocation in study hab-084 (208127/084), and received no further dose of any hepatitis a and/or b vaccine since then.
boolean
C0593953 (UMLS CUI [1])
Informed Consent
Item
written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Immunosuppressive Agents
Item
chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to study entry. inhaled and topical steroids are allowed.
boolean
C0021081 (UMLS CUI [1])
C0279021 (UMLS CUI [2])
C0279021 (UMLS CUI [2])
Immune-modulator therapy
Item
administration of long-acting immune-modifying drugs within six months prior to the study entry.
boolean
C0279021 (UMLS CUI [1])
Study Subject Participation Status
Item
concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
boolean
C2348568 (UMLS CUI [1])
Administration of any hepatitis a and/or b vaccine
Item
administration of any hepatitis a and/or b vaccine at any time since completion of the primary vaccination series in hab-084 (208127/084) study, including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.
boolean
C0593947 (UMLS CUI [1])
History of hepatitis a or b
Item
documented history of hepatitis a or b disease since completion of the primary vaccination series in hab-084 (208127/084) study.
boolean
C1875244 (UMLS CUI [1])
Suspected immunosuppressive or immunologic deficiency syndromes
Item
any confirmed or suspected immunosuppressive or immunologic deficiency syndromes, based on medical history and physical examination (no laboratory testing required).
boolean
C0021079 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0021051 (UMLS CUI [2])
Immunoglobulins
Item
administration of immunoglobulins within six months prior to study entry.
boolean
C0021027 (UMLS CUI [1])