ID

20886

Description

Safety and Immunogenicity Study of an Inactivated Hepatitis A Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00534885

Link

https://clinicaltrials.gov/show/NCT00534885

Keywords

Versions (1)
  1. 3/24/17 3/24/17 -
Uploaded on

March 24, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis A NCT00534885

English

Eligibility Hepatitis A NCT00534885

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
health children from 1 to 10 years
Description

Well child | Age

Data type

boolean

Alias
UMLS CUI [1]
C0686744
UMLS CUI [2]
C0001779
not participate in any other trial during the course of the trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any history of allergic reactions or convulsions following vaccination
Description

Allergic Reaction Vaccination | Convulsions Status post Vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0042196
UMLS CUI [2,1]
C4048158
UMLS CUI [2,2]
C0231290
UMLS CUI [2,3]
C0042196
other known or planned vaccination within 1 month prior to the study and during the study period
Description

Vaccination | Vaccination Planned

Data type

boolean

Alias
UMLS CUI [1]
C0042196
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C1301732
any chronic illness/disease including virus hepatitis, tuberculosis and epilepsy
Description

Chronic disease | Viral hepatitis | Tuberculosis | Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0008679
UMLS CUI [2]
C0042721
UMLS CUI [3]
C0041296
UMLS CUI [4]
C0014544
presence of any congenital abnormality, upgrowth obstacle
Description

Congenital Abnormality | Developmental Disability

Data type

boolean

Alias
UMLS CUI [1]
C0000768
UMLS CUI [2]
C0008073
any history/suspicion/presence of neurology and lunacy
Description

Nervous system disorder | Nervous system disorder Suspicion | Lunacy | Lunacy Suspicion

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0242114
UMLS CUI [3]
C1411138
UMLS CUI [4,1]
C1411138
UMLS CUI [4,2]
C0242114
any current or foreseeable use of immunosuppressors (i.e. corticosteroids , immunoglobulins) within 1 month prior to the vaccination and during the period of the study
Description

Immunosuppressive Agents | Adrenal Cortex Hormones | Immunoglobulins

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0021027
contraindication to intramuscularly injection due to thrombocytopenia or other bleeding disorders
Description

Medical contraindication Intramuscular injection | Thrombocytopenia | Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0021492
UMLS CUI [2]
C0040034
UMLS CUI [3]
C0005779
abnormal alt
Description

Alanine aminotransferase (ALT) abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0580469
positive markers for anti-hav and hbv（hbsag）infection
Description

Hepatitis A virus antibodies Positive Infection | Hepatitis B antibody positive Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0062524
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C3714514
UMLS CUI [2,1]
C0860013
UMLS CUI [2,2]
C3714514
presence of fever at the time of vaccination, i.e. body temperature (by mouth) > 37.0 centigrade.
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
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Similar models

Eligibility Hepatitis A NCT00534885

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Well child | Age
Item
health children from 1 to 10 years
boolean
C0686744 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Study Subject Participation Status
Item
not participate in any other trial during the course of the trial
boolean
C2348568 (UMLS CUI [1])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Vaccination | Convulsions Status post Vaccination
Item
any history of allergic reactions or convulsions following vaccination
boolean
C1527304 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C4048158 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
Vaccination | Vaccination Planned
Item
other known or planned vaccination within 1 month prior to the study and during the study period
boolean
C0042196 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Chronic disease | Viral hepatitis | Tuberculosis | Epilepsy
Item
any chronic illness/disease including virus hepatitis, tuberculosis and epilepsy
boolean
C0008679 (UMLS CUI [1])
C0042721 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
C0014544 (UMLS CUI [4])
Congenital Abnormality | Developmental Disability
Item
presence of any congenital abnormality, upgrowth obstacle
boolean
C0000768 (UMLS CUI [1])
C0008073 (UMLS CUI [2])
Nervous system disorder | Nervous system disorder Suspicion | Lunacy | Lunacy Suspicion
Item
any history/suspicion/presence of neurology and lunacy
boolean
C0027765 (UMLS CUI [1])
C0027765 (UMLS CUI [2,1])
C0242114 (UMLS CUI [2,2])
C1411138 (UMLS CUI [3])
C1411138 (UMLS CUI [4,1])
C0242114 (UMLS CUI [4,2])
Immunosuppressive Agents | Adrenal Cortex Hormones | Immunoglobulins
Item
any current or foreseeable use of immunosuppressors (i.e. corticosteroids , immunoglobulins) within 1 month prior to the vaccination and during the period of the study
boolean
C0021081 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0021027 (UMLS CUI [3])
Medical contraindication Intramuscular injection | Thrombocytopenia | Blood Coagulation Disorders
Item
contraindication to intramuscularly injection due to thrombocytopenia or other bleeding disorders
boolean
C1301624 (UMLS CUI [1,1])
C0021492 (UMLS CUI [1,2])
C0040034 (UMLS CUI [2])
C0005779 (UMLS CUI [3])
Alanine aminotransferase (ALT) abnormal
Item
abnormal alt
boolean
C0580469 (UMLS CUI [1])
Hepatitis A virus antibodies Positive Infection | Hepatitis B antibody positive Infection
Item
positive markers for anti-hav and hbv（hbsag）infection
boolean
C0062524 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
C0860013 (UMLS CUI [2,1])
C3714514 (UMLS CUI [2,2])
Fever
Item
presence of fever at the time of vaccination, i.e. body temperature (by mouth) > 37.0 centigrade.
boolean
C0015967 (UMLS CUI [1])
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