ID

23147

Descripción

Clinical Trial of Recombinant Hepatitis E Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT01014845

Link

https://clinicaltrials.gov/show/NCT01014845

Palabras clave

Versiones (1)
  1. 26/6/17 26/6/17 -
Subido en

26 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis E NCT01014845

Inglés

Eligibility Hepatitis E NCT01014845

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy people aged from 16 years to 65 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
Descripción

ID.1

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0424576
UMLS CUI [1,3]
C1168057
UMLS CUI [1,4]
C0021430
subjects will reside in the study region in the next 19 months.
Descripción

ID.2

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1550511
free of history of hepatitis b or hepatitis e.
Descripción

ID.3

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332122
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0085293
can comply with the request of study.
Descripción

ID.4

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
axillary temperature is below 37 degree centigrade.
Descripción

ID.5

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1531924
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
having other vaccine or immunoglobulin within two weeks;
Descripción

ID.7

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0021027
having allergic history to vaccine and medicine
Descripción

ID.8

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0571550
eclampsia, epilepsy, encephalopathy and history of mental disease or family;
Descripción

ID.9

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0013537
UMLS CUI [1,3]
C0014544
UMLS CUI [1,4]
C0085584
thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
Descripción

ID.10

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C0005779
fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment(radiation therapy, chemical treatment, steroid hormone, antimetabolites, cytotoxic drugs), genetic defect(e.g. fabism), hiv or other factors;
Descripción

ID.11

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0021051
congenital malformation, eccyliosis or severe chronic disease(e.g. down syndrome, diabetes, sickle cell anemia or mental disease);
Descripción

ID.12

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012634
fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
Descripción

ID.13

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012634
joining other clinical study undergoing;
Descripción

ID.14

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0008976
women pregnant or in lactation.
Descripción

ID.15

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
severe allergy for dose 1 or 2;
Descripción

ID.17

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020517
severe adverse reaction associated with last vaccination;
Descripción

ID.18

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0042196
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Similar models

Eligibility Hepatitis E NCT01014845

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
healthy people aged from 16 years to 65 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
boolean
C0001779 (UMLS CUI [1,1])
C0424576 (UMLS CUI [1,2])
C1168057 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
ID.2
Item
subjects will reside in the study region in the next 19 months.
boolean
C1550511 (UMLS CUI [1])
ID.3
Item
free of history of hepatitis b or hepatitis e.
boolean
C0332122 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0085293 (UMLS CUI [1,3])
ID.4
Item
can comply with the request of study.
boolean
C1321605 (UMLS CUI [1])
ID.5
Item
axillary temperature is below 37 degree centigrade.
boolean
C1531924 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.7
Item
having other vaccine or immunoglobulin within two weeks;
boolean
C0042196 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
ID.8
Item
having allergic history to vaccine and medicine
boolean
C0571550 (UMLS CUI [1])
ID.9
Item
eclampsia, epilepsy, encephalopathy and history of mental disease or family;
boolean
C0004936 (UMLS CUI [1,1])
C0013537 (UMLS CUI [1,2])
C0014544 (UMLS CUI [1,3])
C0085584 (UMLS CUI [1,4])
ID.10
Item
thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
boolean
C0040034 (UMLS CUI [1,1])
C0005779 (UMLS CUI [1,2])
ID.11
Item
fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment(radiation therapy, chemical treatment, steroid hormone, antimetabolites, cytotoxic drugs), genetic defect(e.g. fabism), hiv or other factors;
boolean
C0021081 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
ID.12
Item
congenital malformation, eccyliosis or severe chronic disease(e.g. down syndrome, diabetes, sickle cell anemia or mental disease);
boolean
C0012634 (UMLS CUI [1])
ID.13
Item
fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
boolean
C0012634 (UMLS CUI [1])
ID.14
Item
joining other clinical study undergoing;
boolean
C0008976 (UMLS CUI [1])
ID.15
Item
women pregnant or in lactation.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.17
Item
severe allergy for dose 1 or 2;
boolean
C0020517 (UMLS CUI [1])
ID.18
Item
severe adverse reaction associated with last vaccination;
boolean
C0559546 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
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