ID

23048

Description

Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00511095

Link

https://clinicaltrials.gov/show/NCT00511095

Keywords

  1. 6/21/17 6/21/17 -
Uploaded on

June 21, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Hepatitis B NCT00511095

Eligibility Hepatitis B NCT00511095

Inclusion Criteria
Description

Inclusion Criteria

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

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C0021430
women of childbearing potential must be willing to consistently use a highly effective method of birth control
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C0009862
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding
Description

ID.3

Data type

boolean

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

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C0019169
previous vaccination (1 or more doses) with any hbv vaccine
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0474232
any previous autoimmune diseases
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C0004364
are at high risk for recent exposure to hbv, hepatitis c virus (hcv) or human immunodeficiency virus (hiv)
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0220847
UMLS CUI [1,4]
C0019682
received any blood products or antibodies within 3 months prior to study entry
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C0003241
ever received an injection with dna plasmids or oligonucleotides
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1,1]
C4086231
UMLS CUI [1,2]
C0028953
received any vaccines within 4 weeks prior to study entry
Description

ID.10

Data type

boolean

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

ID.11

Data type

boolean

Alias
UMLS CUI [1]
C0013230

Similar models

Eligibility Hepatitis B NCT00511095

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
willing and able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
ID.2
Item
women of childbearing potential must be willing to consistently use a highly effective method of birth control
boolean
C0009862 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.3
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
ID.4
Item
any previous hbv infection
boolean
C0019169 (UMLS CUI [1])
ID.5
Item
previous vaccination (1 or more doses) with any hbv vaccine
boolean
C0474232 (UMLS CUI [1])
ID.6
Item
any previous autoimmune diseases
boolean
C0004364 (UMLS CUI [1])
ID.7
Item
are at high risk for recent exposure to hbv, hepatitis c virus (hcv) or human immunodeficiency virus (hiv)
boolean
C0332167 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0220847 (UMLS CUI [1,3])
C0019682 (UMLS CUI [1,4])
ID.8
Item
received any blood products or antibodies within 3 months prior to study entry
boolean
C0456388 (UMLS CUI [1,1])
C0003241 (UMLS CUI [1,2])
ID.9
Item
ever received an injection with dna plasmids or oligonucleotides
boolean
C4086231 (UMLS CUI [1,1])
C0028953 (UMLS CUI [1,2])
ID.10
Item
received any vaccines within 4 weeks prior to study entry
boolean
C0042210 (UMLS CUI [1])
ID.11
Item
received any other investigational medicinal agent within 4 weeks prior to study entry
boolean
C0013230 (UMLS CUI [1])

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