ID

23146

Description

Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.; ODM derived from: https://clinicaltrials.gov/show/NCT00519649

Link

https://clinicaltrials.gov/show/NCT00519649

Keywords

  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 Vaccine NCT00519649

Eligibility Hepatitis B Vaccine NCT00519649

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who the investigator believes that their parents/guardians 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 of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C0001779
with documented evidence of previous vaccination with three consecutive doses of engerix™-b in germany
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1,1]
C0720215
UMLS CUI [1,2]
C0419728
written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
Description

ID.4

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.5

Data type

boolean

Alias
UMLS CUI [1]
C0424576
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.6

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0013230
evidence of previous hepatitis b booster vaccination since administration of the third dose of engerix™-b vaccine.
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C0419731
history of or intercurrent hepatitis b disease.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0019163
hepatitis b vaccination at birth.
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1,1]
C0474232
UMLS CUI [1,2]
C2599577
planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before hbv vaccine challenge and ending 30 days after.
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C0042196
administration of immunoglobulins and/or any blood products within the three months preceding hbv vaccine challenge or planned administration during the study period.
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0456388
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hbv vaccine challenge.
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1]
C0021081
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1]
C0021051

Similar models

Eligibility Hepatitis B Vaccine NCT00519649

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
boolean
C1321605 (UMLS CUI [1])
ID.2
Item
a male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
with documented evidence of previous vaccination with three consecutive doses of engerix™-b in germany
boolean
C0720215 (UMLS CUI [1,1])
C0419728 (UMLS CUI [1,2])
ID.4
Item
written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
boolean
C0021430 (UMLS CUI [1])
ID.5
Item
healthy subjects as established by medical history and clinical examination before entering into the study.
boolean
C0424576 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.6
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.7
Item
evidence of previous hepatitis b booster vaccination since administration of the third dose of engerix™-b vaccine.
boolean
C0419731 (UMLS CUI [1])
ID.8
Item
history of or intercurrent hepatitis b disease.
boolean
C0019163 (UMLS CUI [1])
ID.9
Item
hepatitis b vaccination at birth.
boolean
C0474232 (UMLS CUI [1,1])
C2599577 (UMLS CUI [1,2])
ID.10
Item
planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before hbv vaccine challenge and ending 30 days after.
boolean
C0042196 (UMLS CUI [1])
ID.11
Item
administration of immunoglobulins and/or any blood products within the three months preceding hbv vaccine challenge or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
ID.12
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hbv vaccine challenge.
boolean
C0021081 (UMLS CUI [1])
ID.13
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
boolean
C0021051 (UMLS CUI [1])

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