ID

23048

Beschrijving

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

Trefwoorden

  1. 21-06-17 21-06-17 -
Geüploaded op

21 juni 2017

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 NCT00511095

Eligibility Hepatitis B NCT00511095

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

ID.1

Datatype

boolean

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

ID.2

Datatype

boolean

Alias
UMLS CUI [1]
C0009862
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding
Beschrijving

ID.3

Datatype

boolean

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

ID.4

Datatype

boolean

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

ID.5

Datatype

boolean

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

ID.6

Datatype

boolean

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

ID.7

Datatype

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
Beschrijving

ID.8

Datatype

boolean

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

ID.9

Datatype

boolean

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

ID.10

Datatype

boolean

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

ID.11

Datatype

boolean

Alias
UMLS CUI [1]
C0013230

Similar models

Eligibility Hepatitis B NCT00511095

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

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