ID

13117

Description

A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.; ODM derived from: https://clinicaltrials.gov/show/NCT00287469

Link

https://clinicaltrials.gov/show/NCT00287469

Keywords

Versions (1)
  1. 1/17/16 1/17/16 -
Uploaded on

January 17, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis NCT00287469

English

Eligibility Hepatitis NCT00287469

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT00287469
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a male or female 18 years of age or older at the time of the first vaccination.
Description

first vaccination

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0042196
UMLS CUI [3]
C0079399
written or oral witnessed (if the subject was illiterate) informed consent obtained from the subject
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
free of obvious health problems as established by medical history before entering into the study
Description

health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
if the subject was female, she must have a negative serum pregnancy test within 48 hours prior to each vaccination and must agree to avoid becoming pregnant during the course of vaccination and until 30 days after the last dose of vaccine.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032976
UMLS CUI [2]
C0032961
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within six months of vaccination. for corticosteroids, this will mean prednisone, or equivalent, * 0.5 mg/kg/day. inhaled and topical steroids are allowed.
Description

immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0021079
any chronic drug therapy to be continued during the study period with the exception of contraceptive agents, homeopathic remedies, vitamins, minerals and any other dietary supplements or other drug therapy at the discretion of the investigator.
Description

medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, excluding tetanus toxoid or rabies vaccine.
Description

vaccination

Data type

boolean

Alias
UMLS CUI [1]
C0042196
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection, as reported by the volunteer (testing for hiv will not be performed).
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Description

hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
major congenital defects or serious chronic illness.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
history of any neurologic disorders or seizures.
Description

neurologic disorders

Data type

boolean

Alias
UMLS CUI [1]
C0027765
acute disease at the time of enrollment. acute disease was defined as the presence of a moderate or severe illness with or without fever. all vaccines could be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature < 38.0°c (100.4°f).
Description

acute disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0001314
acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Description

immunoglobulins, blood products

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
pregnant female.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
history of chronic alcohol consumption (defined as the consumption of the equivalent of 4 or more 12 ounce beers 4 or more times a week) and/or intravenous drug abuse.
Description

substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
antibodies to rhev (* 20 wr u/ml).
Description

antibodies

Data type

boolean

Alias
UMLS CUI [1]
C0003241
Back to the top of the page

Similar models

Eligibility Hepatitis NCT00287469

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Hepatitis NCT00287469
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
first vaccination
Item
a male or female 18 years of age or older at the time of the first vaccination.
boolean
C0001779 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
informed consent
Item
written or oral witnessed (if the subject was illiterate) informed consent obtained from the subject
boolean
C0021430 (UMLS CUI [1])
health status
Item
free of obvious health problems as established by medical history before entering into the study
boolean
C0018759 (UMLS CUI [1])
pregnancy
Item
if the subject was female, she must have a negative serum pregnancy test within 48 hours prior to each vaccination and must agree to avoid becoming pregnant during the course of vaccination and until 30 days after the last dose of vaccine.
boolean
C0032976 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
study subject participation status
Item
use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
C2348568 (UMLS CUI [1])
immunosuppression
Item
administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within six months of vaccination. for corticosteroids, this will mean prednisone, or equivalent, * 0.5 mg/kg/day. inhaled and topical steroids are allowed.
boolean
C0021079 (UMLS CUI [1])
medication
Item
any chronic drug therapy to be continued during the study period with the exception of contraceptive agents, homeopathic remedies, vitamins, minerals and any other dietary supplements or other drug therapy at the discretion of the investigator.
boolean
C0013227 (UMLS CUI [1])
vaccination
Item
planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, excluding tetanus toxoid or rabies vaccine.
boolean
C0042196 (UMLS CUI [1])
comorbidity
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection, as reported by the volunteer (testing for hiv will not be performed).
boolean
C0009488 (UMLS CUI [1])
hypersensitivity
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
comorbidity
Item
major congenital defects or serious chronic illness.
boolean
C0009488 (UMLS CUI [1])
neurologic disorders
Item
history of any neurologic disorders or seizures.
boolean
C0027765 (UMLS CUI [1])
acute disease
Item
acute disease at the time of enrollment. acute disease was defined as the presence of a moderate or severe illness with or without fever. all vaccines could be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature < 38.0°c (100.4°f).
boolean
C0009488 (UMLS CUI [1,1])
C0001314 (UMLS CUI [1,2])
comorbidity
Item
acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history.
boolean
C0009488 (UMLS CUI [1])
immunoglobulins, blood products
Item
administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
pregnancy
Item
pregnant female.
boolean
C0032961 (UMLS CUI [1])
substance abuse
Item
history of chronic alcohol consumption (defined as the consumption of the equivalent of 4 or more 12 ounce beers 4 or more times a week) and/or intravenous drug abuse.
boolean
C0038586 (UMLS CUI [1])
antibodies
Item
antibodies to rhev (* 20 wr u/ml).
boolean
C0003241 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial