Eligibility

  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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