ID

29588

Beskrivning

Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.; ODM derived from: https://clinicaltrials.gov/show/NCT00456625

Länk

https://clinicaltrials.gov/show/NCT00456625

Nyckelord

Versioner (1)
  1. 2018-04-08 2018-04-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00456625

Engelsk

Eligibility Hepatitis B NCT00456625

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
a male or female adult who received the complete neonatal primary vaccination course of hepatitis b vaccine in primary study approximately 20 years earlier.
Beskrivning

Adult | Vaccination Primary Neonatal | Hepatitis B Vaccines

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C2939425
UMLS CUI [3]
C2240392
documented level of anti-hbs antibody concentrations < specified concentration at the previous long-term time point for which serological results are available for that subject.
Beskrivning

Hepatitis B surface antibody measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201478
written informed consent obtained from the subject.
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 Volunteers Medical History | Healthy Volunteers 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
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 completion of the hepatitis b challenge dose.
Beskrivning

Gender | Childbearing Potential Absent | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0427780
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hepatitis b vaccine challenge dose.
Beskrivning

Immunosuppressive Agents chronic | Biological Response Modifiers chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
administration of a vaccine not foreseen by the study protocol during the study period.
Beskrivning

Vaccine | Exception Study Protocol Vaccine

Datatyp

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0042210
administration of immunoglobulins and/or any blood products during the study period.
Beskrivning

Immunoglobulins | Blood product

Datatyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
drug and/or alcohol abuse.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Hepatitis B NCT00456625

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Protocol Compliance
Item
subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
boolean
C0525058 (UMLS CUI [1])
Adult | Vaccination Primary Neonatal | Hepatitis B Vaccines
Item
a male or female adult who received the complete neonatal primary vaccination course of hepatitis b vaccine in primary study approximately 20 years earlier.
boolean
C0001675 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C2939425 (UMLS CUI [2,3])
C2240392 (UMLS CUI [3])
Hepatitis B surface antibody measurement
Item
documented level of anti-hbs antibody concentrations < specified concentration at the previous long-term time point for which serological results are available for that subject.
boolean
C0201478 (UMLS CUI [1])
Informed Consent
Item
written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Healthy Volunteers Medical History | Healthy Volunteers 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])
Gender | Childbearing Potential Absent | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative
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 completion of the hepatitis b challenge dose.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Immunosuppressive Agents chronic | Biological Response Modifiers chronic
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the hepatitis b vaccine challenge dose.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Vaccine | Exception Study Protocol Vaccine
Item
administration of a vaccine not foreseen by the study protocol during the study period.
boolean
C0042210 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
Immunoglobulins | Blood product
Item
administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Substance Use Disorders
Item
drug and/or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
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