Informações:
Falhas:
ID
23049
Descrição
Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00524576
Link
https://clinicaltrials.gov/show/NCT00524576
Palavras-chave
Versões (1)
- 21/06/2017 21/06/2017 -
Transferido a
21 de junho de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00524576
Eligibility Hepatitis B NCT00524576
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT00524576
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
ID.1
Item
subjects who the investigator believes that they can and will comply with the requirements of the protocol.
boolean
C1321605 (UMLS CUI [1])
ID.2
Item
a male or female who had received complete primary vaccination course of hepatitis b vaccine in the primary study
boolean
C0474232 (UMLS CUI [1])
ID.3
Item
written informed consent obtained from the subject and/or parent/guardian of the subject.
boolean
C0021430 (UMLS CUI [1])
ID.4
Item
healthy subjects as established by medical history and clinical examination before entering into the study.
boolean
C0262926 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
ID.5
Item
if the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after the hepatitis b challenge dose.
boolean
C0009862 (UMLS CUI [1])
ID.6
Item
use of any investigational/non-registered drug or vaccine other than the study vaccine within 30 days preceding the hepatitis b vaccine challenge dose or planned use during the study period.
boolean
C0013230 (UMLS CUI [1])
ID.7
Item
chronic administration (more than 14 days) of immunosuppressants other immune-modifying drugs within six months prior to the hepatitis b vaccine challenge dose.
boolean
C0021081 (UMLS CUI [1])
ID.8
Item
planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the hepatitis b vaccine challenge dose and ending 30 days after.
boolean
C0042196 (UMLS CUI [1])
ID.9
Item
subjects who received an additional dose of hepatitis b vaccine outside the context of the study between the primary vaccination course and the hepatitis b challenge vaccination visit.
boolean
C0042196 (UMLS CUI [1])
ID.10
Item
concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
boolean
C0008976 (UMLS CUI [1])
ID.11
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1])
ID.12
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
boolean
C0021051 (UMLS CUI [1])
ID.13
Item
acute disease at the time of enrolment.
boolean
C0012634 (UMLS CUI [1])
ID.14
Item
acute or chronic, clinically significant hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
C0012634 (UMLS CUI [1])
ID.15
Item
administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis b vaccine challenge dose or planned administration during the study period (one month).
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C0456388 (UMLS CUI [1,2])
ID.16
Item
pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
ID.17
Item
female planning to become pregnant or planning to discontinue contraceptive precautions.
boolean
C0032961 (UMLS CUI [1,1])
C0009862 (UMLS CUI [1,2])
C0009862 (UMLS CUI [1,2])