ID

33805

Beschrijving

Hepatitis B Challenge Dose in Adults; ODM derived from: https://clinicaltrials.gov/show/NCT01251276

Link

https://clinicaltrials.gov/show/NCT01251276

Trefwoorden

  1. 28-12-18 28-12-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 december 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hepatitis B NCT01251276

Eligibility Hepatitis B NCT01251276

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
in general good health based on a medical history.
Beschrijving

General health good Medical History

Datatype

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C0262926
received 3 doses of an hepatitis b vaccine at least 2 years prior to enrollment in this study.
Beschrijving

Hepatitis B Vaccine Dose Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known history of previous hepatitis b infection.
Beschrijving

Hepatitis B Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0205156
history of vaccination with any hepatitis b vaccine within the last 2 years.
Beschrijving

History of hepatitis B vaccination

Datatype

boolean

Alias
UMLS CUI [1]
C1960633
history of febrile illness.
Beschrijving

Febrile illness

Datatype

boolean

Alias
UMLS CUI [1]
C0743841
known or suspected hypersensitivity to any component of hbvaxpro.
Beschrijving

Hypersensitivity Component Hepatitis B virus recombinant vaccine | Hypersensitivity Suspected Component Hepatitis B virus recombinant vaccine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C1445761
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C1705248
UMLS CUI [2,4]
C1445761
receipt of medication / vaccine that may interfere with study assessments.
Beschrijving

Pharmaceutical Preparation Interferes with Trial Assessment | Vaccine Interferes with Trial Assessment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1516048
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C1516048
known or suspected immune impairment.
Beschrijving

Immune system Impairment | Immune system Impairment Suspected

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020962
UMLS CUI [1,2]
C0221099
UMLS CUI [2,1]
C0020962
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0750491
pregnant women and nursing mothers.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Hepatitis B NCT01251276

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
General health good Medical History
Item
in general good health based on a medical history.
boolean
C1277245 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Hepatitis B Vaccine Dose Quantity
Item
received 3 doses of an hepatitis b vaccine at least 2 years prior to enrollment in this study.
boolean
C2240392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hepatitis B Previous
Item
known history of previous hepatitis b infection.
boolean
C0019163 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
History of hepatitis B vaccination
Item
history of vaccination with any hepatitis b vaccine within the last 2 years.
boolean
C1960633 (UMLS CUI [1])
Febrile illness
Item
history of febrile illness.
boolean
C0743841 (UMLS CUI [1])
Hypersensitivity Component Hepatitis B virus recombinant vaccine | Hypersensitivity Suspected Component Hepatitis B virus recombinant vaccine
Item
known or suspected hypersensitivity to any component of hbvaxpro.
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C1445761 (UMLS CUI [2,4])
Pharmaceutical Preparation Interferes with Trial Assessment | Vaccine Interferes with Trial Assessment
Item
receipt of medication / vaccine that may interfere with study assessments.
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
C0042210 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])
Immune system Impairment | Immune system Impairment Suspected
Item
known or suspected immune impairment.
boolean
C0020962 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0020962 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant women and nursing mothers.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial