ID

20911

Description

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

Keywords

  1. 3/27/17 3/27/17 -
Uploaded on

March 27, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hepatitis B NCT00435812

Eligibility Hepatitis B NCT00435812

Inclusion Criteria
Description

Inclusion Criteria

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

Informed Consent

Data type

boolean

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

Hepatitis B Antibodies Seronegative

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Hepatitis B

Data type

boolean

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

Vaccination Hepatitis B Vaccine Dose Quantity

Data type

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
Description

Autoimmune Disease

Data type

boolean

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

Blood product | Antibodies

Data type

boolean

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

Plasmid DNA Injection | Oligonucleotides Injection

Data type

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
Description

Vaccines

Data type

boolean

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

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230

Similar models

Eligibility Hepatitis B NCT00435812

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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