ID

39547

Beschreibung

A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children; ODM derived from: https://clinicaltrials.gov/show/NCT01349829

Link

https://clinicaltrials.gov/show/NCT01349829

Stichworte

Versionen (1)
  1. 26.01.20 26.01.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

26. Januar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis A NCT01349829

Englisch

Eligibility Hepatitis A NCT01349829

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
a male or female between (and including) 18 months to 47 months of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent obtained from the parent/legal guardian of the subject.
Beschreibung

Informed Consent Parent | Informed Consent Guardian

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
free of obvious health problems as established by medical history and/or clinical examination before entering the study
Beschreibung

Free of Health problem | Medical History | Clinical Examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332296
UMLS CUI [1,2]
C0018684
UMLS CUI [1,3]
C0033213
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
seropositive for anti-hav antibodies (>=10 miu/ml).
Beschreibung

Hepatitis A virus antibodies Seropositive | Hepatitis A virus antibody measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0062524
UMLS CUI [1,2]
C0521143
UMLS CUI [2]
C0201473
use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up.
Beschreibung

Investigational New Drugs | Drugs, Non-Prescription | INVESTIGATIONAL VACCINES | Investigational New Drugs Planned | Non-Prescription Drugs Planned | INVESTIGATIONAL VACCINES Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3]
C1875384
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C1301732
UMLS CUI [5,1]
C0013231
UMLS CUI [5,2]
C1301732
UMLS CUI [6,1]
C1875384
UMLS CUI [6,2]
C1301732
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, such as prednisone, or equivalent, >=0.5 mg/kg/day.
Beschreibung

Immunosuppressive Agents chronic | Biological Response Modifiers chronic | Adrenal Cortex Hormones By Inhalation allowed | Adrenal Cortex Hormones Local allowed | Prednisone By Inhalation U/day allowed | Prednisone Local U/day allowed | Equivalent U/day allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0205535
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0205276
UMLS CUI [4,3]
C0683607
UMLS CUI [5,1]
C0032952
UMLS CUI [5,2]
C0205535
UMLS CUI [5,3]
C0456683
UMLS CUI [5,4]
C0683607
UMLS CUI [6,1]
C0032952
UMLS CUI [6,2]
C0205276
UMLS CUI [6,3]
C0456683
UMLS CUI [6,4]
C0683607
UMLS CUI [7,1]
C0205163
UMLS CUI [7,2]
C0456683
UMLS CUI [7,3]
C0683607
inhaled and local steroids are allowed.)
Beschreibung

ID.7

Datentyp

boolean

planned administration/ administration of a measles containing vaccine within 4 weeks prior to and after the first or booster dose of study vaccine.
Beschreibung

Measles Vaccine Planned | Measles Vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025010
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0025010
previous vaccination against hepatitis a.
Beschreibung

Vaccination Previous Hepatitis A

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0019159
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
Beschreibung

Immunosuppression | Immunosuppression Suspected | Immunodeficiency | Immunodeficiency Suspected | HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0021051
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0750491
UMLS CUI [5]
C0019693
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Beschreibung

Hypersensitivity Exacerbation | Allergic Reaction Exacerbation | Etiology Vaccine Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4086268
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C4086268
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0042210
UMLS CUI [3,3]
C1705248
major congenital defects or serious chronic illness.
Beschreibung

Congenital defects Major | Chronic disease Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
acute disease at the time of enrolment
Beschreibung

Acute Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
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Ähnliche Modelle

Eligibility Hepatitis A NCT01349829

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
a male or female between (and including) 18 months to 47 months of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent Parent | Informed Consent Guardian
Item
written informed consent obtained from the parent/legal guardian of the subject.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Free of Health problem | Medical History | Clinical Examination
Item
free of obvious health problems as established by medical history and/or clinical examination before entering the study
boolean
C0332296 (UMLS CUI [1,1])
C0018684 (UMLS CUI [1,2])
C0033213 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hepatitis A virus antibodies Seropositive | Hepatitis A virus antibody measurement
Item
seropositive for anti-hav antibodies (>=10 miu/ml).
boolean
C0062524 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
C0201473 (UMLS CUI [2])
Investigational New Drugs | Drugs, Non-Prescription | INVESTIGATIONAL VACCINES | Investigational New Drugs Planned | Non-Prescription Drugs Planned | INVESTIGATIONAL VACCINES Planned
Item
use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C1875384 (UMLS CUI [3])
C0013230 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0013231 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C1875384 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic | Adrenal Cortex Hormones By Inhalation allowed | Adrenal Cortex Hormones Local allowed | Prednisone By Inhalation U/day allowed | Prednisone Local U/day allowed | Equivalent U/day allowed
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, such as prednisone, or equivalent, >=0.5 mg/kg/day.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0001617 (UMLS CUI [4,1])
C0205276 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0032952 (UMLS CUI [5,1])
C0205535 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
C0683607 (UMLS CUI [5,4])
C0032952 (UMLS CUI [6,1])
C0205276 (UMLS CUI [6,2])
C0456683 (UMLS CUI [6,3])
C0683607 (UMLS CUI [6,4])
C0205163 (UMLS CUI [7,1])
C0456683 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
ID.7
Item
inhaled and local steroids are allowed.)
boolean
Measles Vaccine Planned | Measles Vaccine
Item
planned administration/ administration of a measles containing vaccine within 4 weeks prior to and after the first or booster dose of study vaccine.
boolean
C0025010 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0025010 (UMLS CUI [2])
Vaccination Previous Hepatitis A
Item
previous vaccination against hepatitis a.
boolean
C0042196 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0019159 (UMLS CUI [1,3])
Immunosuppression | Immunosuppression Suspected | Immunodeficiency | Immunodeficiency Suspected | HIV Infection
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
boolean
C4048329 (UMLS CUI [1])
C4048329 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0021051 (UMLS CUI [3])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
Hypersensitivity Exacerbation | Allergic Reaction Exacerbation | Etiology Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C4086268 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Congenital defects Major | Chronic disease Serious
Item
major congenital defects or serious chronic illness.
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Acute Disease
Item
acute disease at the time of enrolment
boolean
C0001314 (UMLS CUI [1])
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