ID

40880

Description

Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children; ODM derived from: https://clinicaltrials.gov/show/NCT01333813

Link

https://clinicaltrials.gov/show/NCT01333813

Keywords

Versions (1)
  1. 5/30/20 5/30/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 30, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01333813

English

Eligibility Hepatitis B NCT01333813

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.
Description

Protocol Compliance Parent | Protocol Compliance Patient Representative

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0030701
a male or female 7 to 8 years of age at the time of enrolment.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects with documented evidence of previous vaccination with four consecutive doses of infanrix hexa™ as part of routine vaccination in germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age.
Description

Vaccination Previous | Infanrix hexa Dose Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C3661302
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
written informed consent obtained from the parents/legally acceptable representative(s) of the subject at the time of enrolment.
Description

Informed Consent Parent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
in addition to the informed consent that will be signed by the parent(s)/legally acceptable representative(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator.
Description

Informed Consent

Data type

boolean

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

Healthy Subjects Medical History | Healthy Subjects Clinical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1708335
UMLS CUI [2,2]
C1456356
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
child in care
Description

Child in care

Data type

boolean

Alias
UMLS CUI [1]
C0728735
use of any investigational or non-registered product, other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period.
Description

Investigational New Drugs | Drugs, Non-Prescription | Exception Study Protocol Vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2348563
UMLS CUI [3,3]
C0042210
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 | Clinical Trial | Exposure to Investigational New Drugs | Exposure to Pharmacologic Substance

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0013230
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C1254351
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 Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0419731
UMLS CUI [1,2]
C0205156
history of or intercurrent hepatitis b disease.
Description

History of hepatitis B | Hepatitis B Intercurrent

Data type

boolean

Alias
UMLS CUI [1]
C1997078
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0277557
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 and ending 30 days after the hepatitis b vaccine challenge dose.
Description

Administration of vaccine Planned | Administration of vaccine | Exception Study Protocol Vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C2368628
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2348563
UMLS CUI [3,3]
C0042210
administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration during the study period.
Description

Immunoglobulins | Administration of blood product

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0150150
chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of hbv vaccine.
Description

Immunosuppressive Agents chronic | Immunomodulators chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
history of any reaction or hypersensitivity likely to be exacerbated by any component of the hepatitis b vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis b component.
Description

Allergic Reaction Exacerbated | Hypersensitivity Exacerbated | Etiology Component Hepatitis B Vaccine | Hypersensitivity Post Hepatitis B Vaccine Immunization

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1444749
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1444749
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C1705248
UMLS CUI [3,3]
C2240392
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C2240392
UMLS CUI [4,4]
C0020971
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Description

Immunosuppression | Immunosuppression Suspected | Immunodeficiency | Immunodeficiency Suspected

Data type

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0021051
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0750491
acute disease and/or fever at the time of enrolment.
Description

Acute illness | Fever

Data type

boolean

Alias
UMLS CUI [1]
C4061114
UMLS CUI [2]
C0015967
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Similar models

Eligibility Hepatitis B NCT01333813

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Protocol Compliance Parent | Protocol Compliance Patient Representative
Item
subjects who the investigator believes that their parent(s)/legally acceptable representative(s) 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])
C0030701 (UMLS CUI [2,2])
Age
Item
a male or female 7 to 8 years of age at the time of enrolment.
boolean
C0001779 (UMLS CUI [1])
Vaccination Previous | Infanrix hexa Dose Quantity
Item
subjects with documented evidence of previous vaccination with four consecutive doses of infanrix hexa™ as part of routine vaccination in germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age.
boolean
C0042196 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C3661302 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Informed Consent Parent | Informed Consent Patient Representative
Item
written informed consent obtained from the parents/legally acceptable representative(s) of the subject at the time of enrolment.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Informed Consent
Item
in addition to the informed consent that will be signed by the parent(s)/legally acceptable representative(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator.
boolean
C0021430 (UMLS CUI [1])
Healthy Subjects Medical History | Healthy Subjects Clinical 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])
C1456356 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Child in care
Item
child in care
boolean
C0728735 (UMLS CUI [1])
Investigational New Drugs | Drugs, Non-Prescription | Exception Study Protocol Vaccine
Item
use of any investigational or non-registered product, other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
C0042210 (UMLS CUI [3,3])
Study Subject Participation Status | Clinical Trial | Exposure to Investigational New Drugs | Exposure to Pharmacologic Substance
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])
C0008976 (UMLS CUI [2])
C0332157 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C1254351 (UMLS CUI [4,2])
Booster hepatitis B vaccination Previous
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 [1,1])
C0205156 (UMLS CUI [1,2])
History of hepatitis B | Hepatitis B Intercurrent
Item
history of or intercurrent hepatitis b disease.
boolean
C1997078 (UMLS CUI [1])
C0019163 (UMLS CUI [2,1])
C0277557 (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])
Administration of vaccine Planned | Administration of vaccine | Exception Study Protocol Vaccine
Item
planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the hepatitis b vaccine challenge dose.
boolean
C2368628 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C2368628 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
C0042210 (UMLS CUI [3,3])
Immunoglobulins | Administration of blood product
Item
administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0150150 (UMLS CUI [2])
Immunosuppressive Agents chronic | Immunomodulators chronic
Item
chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of hbv vaccine.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Allergic Reaction Exacerbated | Hypersensitivity Exacerbated | Etiology Component Hepatitis B Vaccine | Hypersensitivity Post Hepatitis B Vaccine Immunization
Item
history of any reaction or hypersensitivity likely to be exacerbated by any component of the hepatitis b vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis b component.
boolean
C1527304 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C1705248 (UMLS CUI [3,2])
C2240392 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C2240392 (UMLS CUI [4,3])
C0020971 (UMLS CUI [4,4])
Immunosuppression | Immunosuppression Suspected | Immunodeficiency | Immunodeficiency Suspected
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
boolean
C4048329 (UMLS CUI [1])
C4048329 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0021051 (UMLS CUI [3])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Acute illness | Fever
Item
acute disease and/or fever at the time of enrolment.
boolean
C4061114 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
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