ID

40880

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01333813

Nyckelord

Versioner (1)
  1. 2020-05-30 2020-05-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 maj 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01333813

Engelsk

Eligibility Hepatitis B NCT01333813

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

Protocol Compliance Parent | Protocol Compliance Patient Representative

Datatyp

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.
Beskrivning

Age

Datatyp

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.
Beskrivning

Vaccination Previous | Infanrix hexa Dose Quantity

Datatyp

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.
Beskrivning

Informed Consent Parent | Informed Consent Patient Representative

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

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

Healthy Subjects Medical History | Healthy Subjects Clinical examination

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
child in care
Beskrivning

Child in care

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Study Subject Participation Status | Clinical Trial | Exposure to Investigational New Drugs | Exposure to Pharmacologic Substance

Datatyp

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.
Beskrivning

Booster hepatitis B vaccination Previous

Datatyp

boolean

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

History of hepatitis B | Hepatitis B Intercurrent

Datatyp

boolean

Alias
UMLS CUI [1]
C1997078
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0277557
hepatitis b vaccination at birth.
Beskrivning

Hepatitis B vaccination at birth

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Immunoglobulins | Administration of blood product

Datatyp

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.
Beskrivning

Immunosuppressive Agents chronic | Immunomodulators chronic

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Immunosuppression | Immunosuppression Suspected | Immunodeficiency | Immunodeficiency Suspected

Datatyp

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.
Beskrivning

Acute illness | Fever

Datatyp

boolean

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

Eligibility Hepatitis B NCT01333813

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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