Información:
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ID
12972
Descripción
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00697853
Link
https://clinicaltrials.gov/show/NCT00697853
Palabras clave
Versiones (1)
- 8/1/16 8/1/16 -
Titular de derechos de autor
CC BY-NC 3.0
Subido en
8 de enero de 2016
DOI
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Licencia
Creative Commons BY-NC 3.0
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Eligibility Hepatitis B NCT00697853
Eligibility Hepatitis B NCT00697853
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT00697853
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
age
Item
a male or female between 15 and 50 years of age at the time of the first vaccination.
boolean
C0001779 (UMLS CUI [1])
health status
Item
free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0018759 (UMLS CUI [1])
informed consent
Item
written informed consent obtained from the subject and/or from the parents or guardians of the subject.
boolean
C0021430 (UMLS CUI [1])
if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination
Item
if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination
boolean
C0700589 (UMLS CUI [1])
medication
Item
use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
boolean
C0013227 (UMLS CUI [1])
administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
Item
administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
boolean
C0021081 (UMLS CUI [1])
planned administration/ administration of a vaccine not foreseen by the study protocol
Item
planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
boolean
C0042196 (UMLS CUI [1])
previous vaccination against hepatitis b
Item
previous vaccination against hepatitis b.
boolean
C0042196 (UMLS CUI [1])
history of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
Item
history of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
boolean
C0009488 (UMLS CUI [1])
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
boolean
C0021051 (UMLS CUI [1])
a family history of congenital or hereditary immunodeficiency.
Item
a family history of congenital or hereditary immunodeficiency.
boolean
C0021051 (UMLS CUI [1])
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1])
acute disease
Item
acute disease at the time of enrollment.
boolean
C0009488 (UMLS CUI [1])
hepatomegaly
Item
hepatomegaly, right upper quadrant abdominal pain or tenderness.
boolean
C0019209 (UMLS CUI [1])
temperature
Item
oral temperature of ≥37.5°c (99.5°f).
boolean
C0039476 (UMLS CUI [1])
immunoglobulins and/or any 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/ administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0456388 (UMLS CUI [2])
pregnant or lactating female
Item
pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
history of chronic alcohol consumption and/or intravenous drug abuse
Item
history of chronic alcohol consumption and/or intravenous drug abuse
boolean
C0038586 (UMLS CUI [1])