ID

44122

Description

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

Keywords

  1. 4/7/19 4/7/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT02203357

Eligibility Hepatitis B NCT02203357

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy subjects aged between 16 and 25 as established by medical history and clinical examination
Description

Healthy Volunteers | Age | Medical History | Clinical examination

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0262926
UMLS CUI [4]
C1456356
written informed consent will be obtained from each subject before the serum screening of hbv markers
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
seronegative for hbsag, anti-hbs antibody, anti-hbc antibody
Description

Seronegative Hepatitis B Surface Antigens | Seronegative Anti-HBs antibody | Seronegative Anti-HBc antibody

Data type

boolean

Alias
UMLS CUI [1,1]
C0521144
UMLS CUI [1,2]
C0019168
UMLS CUI [2,1]
C0521144
UMLS CUI [2,2]
C0201478
UMLS CUI [3,1]
C0521144
UMLS CUI [3,2]
C0948759
have never been immunized with hbv vaccine before
Description

Hepatitis B vaccine Immunization Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C0020971
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has a medical history of allergic to any ingredient of vaccine
Description

Hypersensitivity Vaccine Ingredient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1550600
family history of seizures or progressive neurological disease
Description

Family history Seizures | Family history Nervous system disorder Progressive

Data type

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0036572
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0027765
UMLS CUI [2,3]
C0205329
autoimmune disease or immunodeficiency
Description

Autoimmune Disease | Immunodeficiency

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021051
women with pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
bleeding disorder diagnosed by a doctor
Description

Blood Coagulation Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005779
chronic diseases: hepatitis, tumor, tuberculosis,et.al
Description

Chronic disease | Hepatitis | Malignant Neoplasms | Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0008679
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0006826
UMLS CUI [4]
C0041296
any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment
Description

Immunoglobulins | Blood product

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
subjects had a medical history of serious adverse reactions to vaccines
Description

Adverse reactions Serious Vaccines

Data type

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0042210

Similar models

Eligibility Hepatitis B NCT02203357

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
Autoimmune Disease | Immunodeficiency
Item
autoimmune disease or immunodeficiency
boolean
C0004364 (UMLS CUI [1])
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])
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])
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])

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