Informações:
Falhas:
ID
44122
Descrição
Randomized,Paralleled-group Clinical Trial of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Adults; ODM derived from: https://clinicaltrials.gov/show/NCT02203357
Link
https://clinicaltrials.gov/show/NCT02203357
Palavras-chave
Versões (2)
- 07/04/2019 07/04/2019 -
- 20/09/2021 20/09/2021 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
20 de setembro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis B NCT02203357
Eligibility Hepatitis B NCT02203357
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT02203357
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Healthy Volunteers | Age | Medical History | Clinical examination
Item
healthy subjects aged between 16 and 25 as established by medical history and clinical examination
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C1456356 (UMLS CUI [4])
C0001779 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C1456356 (UMLS CUI [4])
Informed Consent
Item
written informed consent will be obtained from each subject before the serum screening of hbv markers
boolean
C0021430 (UMLS CUI [1])
Seronegative Hepatitis B Surface Antigens | Seronegative Anti-HBs antibody | Seronegative Anti-HBc antibody
Item
seronegative for hbsag, anti-hbs antibody, anti-hbc antibody
boolean
C0521144 (UMLS CUI [1,1])
C0019168 (UMLS CUI [1,2])
C0521144 (UMLS CUI [2,1])
C0201478 (UMLS CUI [2,2])
C0521144 (UMLS CUI [3,1])
C0948759 (UMLS CUI [3,2])
C0019168 (UMLS CUI [1,2])
C0521144 (UMLS CUI [2,1])
C0201478 (UMLS CUI [2,2])
C0521144 (UMLS CUI [3,1])
C0948759 (UMLS CUI [3,2])
Hepatitis B vaccine Immunization Absent
Item
have never been immunized with hbv vaccine before
boolean
C0474232 (UMLS CUI [1,1])
C0020971 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0020971 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Hypersensitivity Vaccine Ingredient
Item
subject has a medical history of allergic to any ingredient of vaccine
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
Family history Seizures | Family history Nervous system disorder Progressive
Item
family history of seizures or progressive neurological disease
boolean
C0241889 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0027765 (UMLS CUI [2,2])
C0205329 (UMLS CUI [2,3])
C0036572 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0027765 (UMLS CUI [2,2])
C0205329 (UMLS CUI [2,3])
Autoimmune Disease | Immunodeficiency
Item
autoimmune disease or immunodeficiency
boolean
C0004364 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0021051 (UMLS CUI [2])
Pregnancy
Item
women with pregnant
boolean
C0032961 (UMLS CUI [1])
Blood Coagulation Disorder
Item
bleeding disorder diagnosed by a doctor
boolean
C0005779 (UMLS CUI [1])
Chronic disease | Hepatitis | Malignant Neoplasms | Tuberculosis
Item
chronic diseases: hepatitis, tumor, tuberculosis,et.al
boolean
C0008679 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0041296 (UMLS CUI [4])
C0019158 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0041296 (UMLS CUI [4])
Immunoglobulins | Blood product
Item
any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0456388 (UMLS CUI [2])
Adverse reactions Serious Vaccines
Item
subjects had a medical history of serious adverse reactions to vaccines
boolean
C0559546 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0205404 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])