ID

4853

Description

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00778388

Link

http://clinicaltrials.gov/ct2/show/record/NCT00778388

Keywords

Versions (2)
  1. 11/23/11 11/23/11 -
  2. 4/13/14 4/13/14 - Julian Varghese
Uploaded on

April 13, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00778388 Pseudomonas Aeruginosa

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

written informed consent obtained prior to study entry
Description

informed consent

Data type

boolean

healthy adults aged between 18 and 65 years
Description

Age

Data type

boolean

no clinically relevant pathological findings in any of the investigations at the Screening visit. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance
Description

Healthy person

Data type

boolean

In female subjects either childbearing potential terminated by surgery or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
Description

Not pregnant during the study

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

History of autoimmune diseases and malignancies
Description

History of autoimmune diseases and malignancies

Data type

boolean

Active or passive vaccination 4 weeks before and during the entire study protocol
Description

vaccination

Data type

boolean

Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
Description

No investigational drug or vaccine

Data type

boolean

History of severe hypersensitivity reactions and anaphylaxis
Description

History of severe hypersensitivity reactions and anaphylaxis

Data type

boolean

Known hypersensitivity or allergic reactions to one of the components of the vaccine
Description

Allergy to vaccine component

Data type

boolean

Clinically significant diseases as judged by the investigator
Description

Significant disease

Data type

boolean

Immunodeficiency due to immunosuppressive therapy
Description

Immunosuppressive therapy

Data type

boolean

A family history of congenital or hereditary immunodeficiency
Description

Immunodeficiency

Data type

boolean

Medical Concepts
Description

Medical Concepts

Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Healthy Subject
Description

Healthy Volunteer

Data type

string

Alias
UMLS CUI
C1708335
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Contraception
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Serum pregnancy test (B-HCG)
Description

Serum pregnancy test

Data type

string

Alias
UMLS CUI
C0430060
SNOMED CT 2010_0731
166434005
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Autoimmune Disease
Description

Autoimmune Disorder

Data type

string

Alias
UMLS CUI
C0004364
SNOMED CT 2010_0731
85828009
MedDRA 13.1
10061664
ICD-10-CM Version 2010
M30-M36
CTCAE Version 4.03
E11258
Malignant Neoplasms
Description

Cancer

Data type

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Vaccination
Description

Vaccination

Data type

string

Alias
UMLS CUI
C0042196
SNOMED CT 2010_0731
33879002
MedDRA 13.1
10046859
LOINC Version 232
MTHU000146
Enrollment
Description

Enrollment

Data type

string

Alias
UMLS CUI
C2348568
Hypersensitivity
Description

Allergy

Data type

string

Alias
UMLS CUI
C0020517
SNOMED CT 2010_0731
257550005
ICD-10-CM Version 2010
T78.40
Immunomodulatory or immunosuppressive therapy
Description

Immunomodulatory or immunosuppressive therapy

Data type

string

Alias
UMLS CUI
C1963758
SNOMED CT 2010_0731
86553008
MedDRA 13.1
10067473
congenital immunodeficiency
Description

congenital immunodeficiency

Data type

string

Alias
UMLS CUI
C0853602
MedDRA 13.1
10021450
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
informed consent
Item
written informed consent obtained prior to study entry
boolean
Age
Item
healthy adults aged between 18 and 65 years
boolean
Healthy person
Item
no clinically relevant pathological findings in any of the investigations at the Screening visit. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance
boolean
Not pregnant during the study
Item
In female subjects either childbearing potential terminated by surgery or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
boolean
Item Group
Exclusion Criteria
History of autoimmune diseases and malignancies
Item
History of autoimmune diseases and malignancies
boolean
vaccination
Item
Active or passive vaccination 4 weeks before and during the entire study protocol
boolean
No investigational drug or vaccine
Item
Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
boolean
History of severe hypersensitivity reactions and anaphylaxis
Item
History of severe hypersensitivity reactions and anaphylaxis
boolean
Allergy to vaccine component
Item
Known hypersensitivity or allergic reactions to one of the components of the vaccine
boolean
Significant disease
Item
Clinically significant diseases as judged by the investigator
boolean
Immunosuppressive therapy
Item
Immunodeficiency due to immunosuppressive therapy
boolean
Immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency
boolean
Item Group
Medical Concepts
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Healthy Volunteer
Item
Healthy Subject
string
C1708335 (UMLS CUI)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Serum pregnancy test
Item
Serum pregnancy test (B-HCG)
string
C0430060 (UMLS CUI)
166434005 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Autoimmune Disorder
Item
Autoimmune Disease
string
C0004364 (UMLS CUI)
85828009 (SNOMED CT 2010_0731)
10061664 (MedDRA 13.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE Version 4.03)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Vaccination
Item
Vaccination
string
C0042196 (UMLS CUI)
33879002 (SNOMED CT 2010_0731)
10046859 (MedDRA 13.1)
MTHU000146 (LOINC Version 232)
Enrollment
Item
Enrollment
string
C2348568 (UMLS CUI)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
Immunomodulatory or immunosuppressive therapy
Item
Immunomodulatory or immunosuppressive therapy
string
C1963758 (UMLS CUI)
86553008 (SNOMED CT 2010_0731)
10067473 (MedDRA 13.1)
congenital immunodeficiency
Item
congenital immunodeficiency
string
C0853602 (UMLS CUI)
10021450 (MedDRA 13.1)
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