ID

23145

Description

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

Keywords

Versions (1)
  1. 6/26/17 6/26/17 -
Uploaded on

June 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00524576

English

Eligibility Hepatitis B NCT00524576

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C1321605
a male or female who had received complete primary vaccination course of hepatitis b vaccine in the primary study
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C0474232
written informed consent obtained from the subject and/or parent/guardian of the subject.
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0021430
healthy subjects as established by medical history and clinical examination before entering into the study.
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C0424576
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.
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0009862
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C0013230
chronic administration (more than 14 days) of immunosuppressants other immune-modifying drugs within six months prior to the hepatitis b vaccine challenge dose.
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C0021081
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.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0042196
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.
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0178602
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.
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0013230
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042196
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1]
C0021051
acute disease at the time of enrolment.
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1]
C0012634
acute or chronic, clinically significant hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Description

ID.14

Data type

boolean

Alias
UMLS CUI [1,1]
C0151746
UMLS CUI [1,2]
C0086565
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).
Description

ID.15

Data type

boolean

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

ID.16

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
female planning to become pregnant or planning to discontinue contraceptive precautions.
Description

ID.17

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Hepatitis B NCT00524576

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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
C0424576 (UMLS CUI [1])
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])
Item Group
C0680251 (UMLS CUI)
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 [1,1])
C1524062 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
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 [1,1])
C0013230 (UMLS CUI [1,2])
ID.11
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
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
C0151746 (UMLS CUI [1,1])
C0086565 (UMLS CUI [1,2])
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])
ID.16
Item
pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.17
Item
female planning to become pregnant or planning to discontinue contraceptive precautions.
boolean
C0032961 (UMLS CUI [1])
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