ID

20911

Beschrijving

Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00435812

Link

https://clinicaltrials.gov/show/NCT00435812

Trefwoorden

  1. 27-03-17 27-03-17 -
Geüploaded op

27 maart 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT00435812

Eligibility Hepatitis B NCT00435812

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
willing and able to give written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
is serum negative for hbv antibodies
Beschrijving

Hepatitis B Antibodies Seronegative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019164
UMLS CUI [1,2]
C0521144
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any previous hbv infection
Beschrijving

Hepatitis B

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
previous vaccination with any hbv vaccine (1 or more doses)
Beschrijving

Vaccination Hepatitis B Vaccine Dose Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2240392
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1265611
any autoimmune disease
Beschrijving

Autoimmune Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
received any blood products or antibodies within 3 months prior to study entry
Beschrijving

Blood product | Antibodies

Datatype

boolean

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2]
C3495458
ever received an injection with dna plasmids or oligonucleotides
Beschrijving

Plasmid DNA Injection | Oligonucleotides Injection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032136
UMLS CUI [1,2]
C1828121
UMLS CUI [2,1]
C0028953
UMLS CUI [2,2]
C1828121
received any vaccines within 4 weeks prior to study entry
Beschrijving

Vaccines

Datatype

boolean

Alias
UMLS CUI [1]
C0042210
received any other investigational medicinal agent within 4 weeks prior to study entry
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230

Similar models

Eligibility Hepatitis B NCT00435812

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
willing and able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Hepatitis B Antibodies Seronegative
Item
is serum negative for hbv antibodies
boolean
C0019164 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B
Item
any previous hbv infection
boolean
C0019163 (UMLS CUI [1])
Vaccination Hepatitis B Vaccine Dose Quantity
Item
previous vaccination with any hbv vaccine (1 or more doses)
boolean
C0042196 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Autoimmune Disease
Item
any autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Blood product | Antibodies
Item
received any blood products or antibodies within 3 months prior to study entry
boolean
C0456388 (UMLS CUI [1])
C3495458 (UMLS CUI [2])
Plasmid DNA Injection | Oligonucleotides Injection
Item
ever received an injection with dna plasmids or oligonucleotides
boolean
C0032136 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0028953 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
Vaccines
Item
received any vaccines within 4 weeks prior to study entry
boolean
C0042210 (UMLS CUI [1])
Investigational New Drugs
Item
received any other investigational medicinal agent within 4 weeks prior to study entry
boolean
C0013230 (UMLS CUI [1])

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