ID

20907

Description

Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge; ODM derived from: https://clinicaltrials.gov/show/NCT00411697

Link

https://clinicaltrials.gov/show/NCT00411697

Keywords

Versions (1)
  1. 3/27/17 3/27/17 -
Uploaded on

March 27, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00411697

English

Eligibility Hepatitis B NCT00411697

1 forms  
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

Protocol Compliance parent | Protocol Compliance Guardian

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1274041
a male or female of 4 to 5 years of age at the time of enrolment.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
with documented evidence of previous vaccination with four consecutive doses of infanrix hexa™ in germany.
Description

Vaccination Evidence of | Infanrix Hexa Dose Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0728745
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
Description

Informed Consent parent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
healthy subjects as established by medical history and clinical examination before entering into the study.
Description

Healthy Volunteers Medical History | Healthy Volunteers Physical Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1708335
UMLS CUI [2,2]
C0031809
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

Study Subject Participation Status | Investigational New Drug Exposure to | Pharmaceutical Preparation Exposure to

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0332157
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332157
evidence of previous hepatitis b booster vaccination since administration of the fourth dose of infanrix hexa™ booster in the second year of life.
Description

Booster hepatitis B vaccination | Infanrix Hexa Secondary Immunization Dose

Data type

boolean

Alias
UMLS CUI [1]
C0419731
UMLS CUI [2,1]
C0728745
UMLS CUI [2,2]
C0020975
UMLS CUI [2,3]
C0178602
history of or intercurrent hepatitis b disease.
Description

Hepatitis B | Hepatitis B Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0009488
hepatitis b vaccination at birth.
Description

Hepatitis B vaccination at birth

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 booster vaccination and ending 30 days after.
Description

Vaccine | Vaccine Planned

Data type

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1301732
administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination or planned administration during the study period.
Description

Immunoglobulins | Blood product | Immunoglobulins Planned | Blood product Planned

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
UMLS CUI [3,1]
C0021027
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0456388
UMLS CUI [4,2]
C1301732
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

Immunosuppressive Agents chronic | Biological Response Modifiers chronic | Hepatitis B Virus Vaccine Challenge

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0019169
UMLS CUI [3,2]
C0042210
UMLS CUI [3,3]
C0805586
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Similar models

Eligibility Hepatitis B NCT00411697

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Protocol Compliance parent | Protocol Compliance Guardian
Item
subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Age
Item
a male or female of 4 to 5 years of age at the time of enrolment.
boolean
C0001779 (UMLS CUI [1])
Vaccination Evidence of | Infanrix Hexa Dose Quantity
Item
with documented evidence of previous vaccination with four consecutive doses of infanrix hexa™ in germany.
boolean
C0042196 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0728745 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Informed Consent parent | Informed Consent Guardian
Item
written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Healthy Volunteers Medical History | Healthy Volunteers Physical Examination
Item
healthy subjects as established by medical history and clinical examination before entering into the study.
boolean
C1708335 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drug Exposure to | Pharmaceutical Preparation Exposure to
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
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
Booster hepatitis B vaccination | Infanrix Hexa Secondary Immunization Dose
Item
evidence of previous hepatitis b booster vaccination since administration of the fourth dose of infanrix hexa™ booster in the second year of life.
boolean
C0419731 (UMLS CUI [1])
C0728745 (UMLS CUI [2,1])
C0020975 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Hepatitis B | Hepatitis B Comorbidity
Item
history of or intercurrent hepatitis b disease.
boolean
C0019163 (UMLS CUI [1])
C0019163 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
Hepatitis B vaccination at birth
Item
hepatitis b vaccination at birth.
boolean
C0474232 (UMLS CUI [1,1])
C2599577 (UMLS CUI [1,2])
Vaccine | Vaccine Planned
Item
planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before booster vaccination and ending 30 days after.
boolean
C0042210 (UMLS CUI [1])
C0042210 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Immunoglobulins | Blood product | Immunoglobulins Planned | Blood product Planned
Item
administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0021027 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0456388 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic | Hepatitis B Virus Vaccine Challenge
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 [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0019169 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
C0805586 (UMLS CUI [3,3])
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