Informatie:
Fout:
ID
13117
Beschrijving
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
Trefwoorden
Versies (1)
- 17-01-16 17-01-16 -
Geüploaded op
17 januari 2016
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Hepatitis NCT00287469
Eligibility Hepatitis NCT00287469
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis NCT00287469
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
C0032961 (UMLS CUI [2])
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])
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])
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])
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])