ID

17465

Beskrivning

Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age; ODM derived from: https://clinicaltrials.gov/show/NCT00197002

Länk

https://clinicaltrials.gov/show/NCT00197002

Nyckelord

Versioner (1)
  1. 2016-09-16 2016-09-16 -
Uppladdad den

16 september 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis A NCT00197002

Engelsk

Eligibility Hepatitis A NCT00197002

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
a male or female child 12 or 13 months of age at the time of entry into the enrollment phase,
Beskrivning

Child | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0001779
free of obvious health problems,
Beskrivning

Health Complaints Free of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0871764
UMLS CUI [1,2]
C0332296
subjects must have previously received three doses of prevnar in his/her first year of life.
Beskrivning

Prevnar Dosage Quantity | Life year First

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0876134
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0376558
UMLS CUI [2,2]
C0439234
UMLS CUI [2,3]
C0205435
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any investigational or non-registered drug or vaccine within 42 days preceding the first dose of study vaccine, or planned use during the study period,
Beskrivning

Investigational New Drug | Drug, Non-Prescription | Vaccine

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3]
C0042210
chronic administration of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (for corticosteroids, this will mean prednisone, or equivalent, less than 0.5 mg/kg/day. inhaled, nasal and topical steroids are allowed.),
Beskrivning

Immunosuppressive Agents chronic | Biological Response Modifiers chronic | Adrenal Cortex Hormones | Prednisone | Prednisone Equivalent | inhaled steroids | Steroids Nasal | topical steroids

Datatyp

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]
C0001617
UMLS CUI [4]
C0032952
UMLS CUI [5,1]
C0032952
UMLS CUI [5,2]
C0205163
UMLS CUI [6]
C2065041
UMLS CUI [7,1]
C0038317
UMLS CUI [7,2]
C1522019
UMLS CUI [8]
C2064827
administration of the acip-recommended fourth dose of prevnar prior to entering the enrollment phase of the study,
Beskrivning

Prevnar Dosage Fourth

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0876134
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205438
planned administration or administration of any vaccine not foreseen by the study protocol within the period of 42 days before and 30 days after each dose of study vaccine(s),
Beskrivning

Administration of vaccine Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
previous vaccination against hepatitis a,
Beskrivning

Hepatitis A immunization

Datatyp

boolean

Alias
UMLS CUI [1]
C0419735
history of hepatitis a or known exposure to hepatitis a,
Beskrivning

Hepatitis A | Hepatitis A Exposure to

Datatyp

boolean

Alias
UMLS CUI [1]
C0019159
UMLS CUI [2,1]
C0019159
UMLS CUI [2,2]
C0332157
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection,
Beskrivning

Immunosuppression | Immunologic Deficiency Syndromes | HIV Infections

Datatyp

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
UMLS CUI [3]
C0019693
a family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for hiv infection,
Beskrivning

Immunodeficiency congenital Family history | Immunologic Deficiency Syndromes Hereditary Family history | HIV Infections Family history | parent risk factors HIV Infections

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853602
UMLS CUI [1,2]
C0241889
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0439660
UMLS CUI [2,3]
C0241889
UMLS CUI [3,1]
C0019693
UMLS CUI [3,2]
C0241889
UMLS CUI [4,1]
C0030551
UMLS CUI [4,2]
C0035648
UMLS CUI [4,3]
C0019693
history of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of havrix (e.g., neomycin, 2-phenoxyethanol) or prevnar (e.g., diphtheria toxoid),
Beskrivning

Hypersensitivity Exacerbated Due to Havrix Component | Allergic Reaction Exacerbated Due to Havrix Component | Neomycin | Phenoxyethanol | Prevnar | diphtheria toxoid

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1444749
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0700881
UMLS CUI [1,5]
C1705248
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1444749
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0700881
UMLS CUI [2,5]
C1705248
UMLS CUI [3]
C0027603
UMLS CUI [4]
C0301042
UMLS CUI [5]
C0876134
UMLS CUI [6]
C0012551
major congenital defects or serious chronic illness,
Beskrivning

Congenital defects Major | Chronic disease Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220810
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
history of any neurologic disorder (history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject),
Beskrivning

nervous system disorder | Febrile Convulsions

Datatyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0009952
acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of vaccination,
Beskrivning

Disease | Illness Moderate | Illness Severe | Illness Moderate Associated with Fever | Illness Severe Associated with Fever

Datatyp

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0205081
UMLS CUI [4,3]
C0332281
UMLS CUI [4,4]
C0015967
UMLS CUI [5,1]
C0221423
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C0332281
UMLS CUI [5,4]
C0015967
administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period.
Beskrivning

Immunoglobulins | Blood product

Datatyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
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Similar models

Eligibility Hepatitis A NCT00197002

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Child | Age
Item
a male or female child 12 or 13 months of age at the time of entry into the enrollment phase,
boolean
C0008059 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Health Complaints Free of
Item
free of obvious health problems,
boolean
C0871764 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
Prevnar Dosage Quantity | Life year First
Item
subjects must have previously received three doses of prevnar in his/her first year of life.
boolean
C0876134 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0376558 (UMLS CUI [2,1])
C0439234 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Investigational New Drug | Drug, Non-Prescription | Vaccine
Item
use of any investigational or non-registered drug or vaccine within 42 days preceding the first dose of study vaccine, or planned use during the study period,
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic | Adrenal Cortex Hormones | Prednisone | Prednisone Equivalent | inhaled steroids | Steroids Nasal | topical steroids
Item
chronic administration of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (for corticosteroids, this will mean prednisone, or equivalent, less than 0.5 mg/kg/day. inhaled, nasal and topical steroids are allowed.),
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])
C0032952 (UMLS CUI [4])
C0032952 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
C2065041 (UMLS CUI [6])
C0038317 (UMLS CUI [7,1])
C1522019 (UMLS CUI [7,2])
C2064827 (UMLS CUI [8])
Prevnar Dosage Fourth
Item
administration of the acip-recommended fourth dose of prevnar prior to entering the enrollment phase of the study,
boolean
C0876134 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205438 (UMLS CUI [1,3])
Administration of vaccine Study Protocol
Item
planned administration or administration of any vaccine not foreseen by the study protocol within the period of 42 days before and 30 days after each dose of study vaccine(s),
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Hepatitis A immunization
Item
previous vaccination against hepatitis a,
boolean
C0419735 (UMLS CUI [1])
Hepatitis A | Hepatitis A Exposure to
Item
history of hepatitis a or known exposure to hepatitis a,
boolean
C0019159 (UMLS CUI [1])
C0019159 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
Immunosuppression | Immunologic Deficiency Syndromes | HIV Infections
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection,
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Immunodeficiency congenital Family history | Immunologic Deficiency Syndromes Hereditary Family history | HIV Infections Family history | parent risk factors HIV Infections
Item
a family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for hiv infection,
boolean
C0853602 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0241889 (UMLS CUI [2,3])
C0019693 (UMLS CUI [3,1])
C0241889 (UMLS CUI [3,2])
C0030551 (UMLS CUI [4,1])
C0035648 (UMLS CUI [4,2])
C0019693 (UMLS CUI [4,3])
Hypersensitivity Exacerbated Due to Havrix Component | Allergic Reaction Exacerbated Due to Havrix Component | Neomycin | Phenoxyethanol | Prevnar | diphtheria toxoid
Item
history of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of havrix (e.g., neomycin, 2-phenoxyethanol) or prevnar (e.g., diphtheria toxoid),
boolean
C0020517 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0700881 (UMLS CUI [1,4])
C1705248 (UMLS CUI [1,5])
C1527304 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0700881 (UMLS CUI [2,4])
C1705248 (UMLS CUI [2,5])
C0027603 (UMLS CUI [3])
C0301042 (UMLS CUI [4])
C0876134 (UMLS CUI [5])
C0012551 (UMLS CUI [6])
Congenital defects Major | Chronic disease Serious
Item
major congenital defects or serious chronic illness,
boolean
C0220810 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
nervous system disorder | Febrile Convulsions
Item
history of any neurologic disorder (history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject),
boolean
C0027765 (UMLS CUI [1])
C0009952 (UMLS CUI [2])
Disease | Illness Moderate | Illness Severe | Illness Moderate Associated with Fever | Illness Severe Associated with Fever
Item
acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of vaccination,
boolean
C0012634 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0221423 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0221423 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
C0332281 (UMLS CUI [4,3])
C0015967 (UMLS CUI [4,4])
C0221423 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0332281 (UMLS CUI [5,3])
C0015967 (UMLS CUI [5,4])
Immunoglobulins | Blood product
Item
administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
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