ID

23883

Beskrivning

Study part: Eligibility Question Visit 1. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

Nyckelord

Versioner (1)
  1. 2017-07-16 2017-07-16 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

16 juli 2017

DOI

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Creative Commons BY-NC 3.0
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Eligibility Question Visit 1 Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

Engelsk

Eligibility Question Visit 1

1 Formulär  
ELIGIBILITY QUESTION
Beskrivning

ELIGIBILITY QUESTION

Alias
UMLS CUI-1
C1516637
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Did the subject meet all the entry criteria ?
Beskrivning

entry criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C1516637
INCLUSION CRITERIA
Beskrivning

INCLUSION CRITERIA

Alias
UMLS CUI-1
C1512693
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
Beskrivning

compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
A male or female between, and including, 12 and 18 months of age at the time of the booster vaccination.
Beskrivning

gender; age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Written informed consent obtained from the parent(s) or guardian(s) of the subject.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Beskrivning

comorbidity; medical history; clinical examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0262926
UMLS CUI [3]
C1456356
Having participated in the primary vaccination study 792014/003.
Beskrivning

study participation status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
EXCLUSION CRITERIA
Beskrivning

EXCLUSION CRITERIA

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster of study vaccine, or planned use during the study period.
Beskrivning

concomitant medication

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Beskrivning

chronic drug usage immunosuppressants corticosteroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0598327
UMLS CUI [1,2]
C0021081
UMLS CUI [1,3]
C0001617
Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the booster dose of vaccine(s).
Beskrivning

vaccine administration

Datatyp

boolean

Alias
UMLS CUI [1]
C2368628
Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C or Y disease except if within the framework of study 792014/003.
Beskrivning

Immunization

Datatyp

boolean

Alias
UMLS CUI [1]
C0020971
Previous vaccination against pneumococcal disease.
Beskrivning

vaccination pneumococcal disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0032269
History of diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C or Y disease.
Beskrivning

medical history diphtheria tetanus pertussis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012546
UMLS CUI [1,3]
C0039614
UMLS CUI [1,4]
C0043167
Known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C or Y disease within the last 3 months.
Beskrivning

exposure (to) disease diphtheria tetanus pertussis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0848543
UMLS CUI [1,2]
C0012546
UMLS CUI [1,3]
C0039614
UMLS CUI [1,4]
C0043167
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Beskrivning

immunodeficient condition HIV infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3829792
UMLS CUI [1,2]
C0019693
A family history of congenital or hereditary immunodeficiency.
Beskrivning

Congenital immunodeficiency disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0272229
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Beskrivning

Hypersensitivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
Major congenital defects or serious chronic illness.
Beskrivning

Chronic disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0008679
History of any neurologic disorders or seizures including febrile seizures in infancy.
Beskrivning

neurologic disorders seizures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0036572
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low- grade febrile illness, i.e., Axillary temperature <37.5°C / Rectal temperature <38°C)
Beskrivning

Acute disease diarrhoea respiratory infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0011991
UMLS CUI [1,3]
C0035243
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Beskrivning

immunoglobulins

Datatyp

boolean

Alias
UMLS CUI [1]
C0021027
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Similar models

Eligibility Question Visit 1

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
ELIGIBILITY QUESTION
C1516637 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
entry criteria
Item
Did the subject meet all the entry criteria ?
boolean
C1516637 (UMLS CUI [1])
Item Group
INCLUSION CRITERIA
C1512693 (UMLS CUI-1)
compliance
Item
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
boolean
C1321605 (UMLS CUI [1])
gender; age
Item
A male or female between, and including, 12 and 18 months of age at the time of the booster vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
informed consent
Item
Written informed consent obtained from the parent(s) or guardian(s) of the subject.
boolean
C0021430 (UMLS CUI [1])
comorbidity; medical history; clinical examination
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0009488 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C1456356 (UMLS CUI [3])
study participation status
Item
Having participated in the primary vaccination study 792014/003.
boolean
C2348568 (UMLS CUI [1])
Item Group
EXCLUSION CRITERIA
C0680251 (UMLS CUI-1)
concomitant medication
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster of study vaccine, or planned use during the study period.
boolean
C2347852 (UMLS CUI [1])
chronic drug usage immunosuppressants corticosteroids
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0598327 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
vaccine administration
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the booster dose of vaccine(s).
boolean
C2368628 (UMLS CUI [1])
Immunization
Item
Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C or Y disease except if within the framework of study 792014/003.
boolean
C0020971 (UMLS CUI [1])
vaccination pneumococcal disease
Item
Previous vaccination against pneumococcal disease.
boolean
C0042196 (UMLS CUI [1,1])
C0032269 (UMLS CUI [1,2])
medical history diphtheria tetanus pertussis
Item
History of diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C or Y disease.
boolean
C0262926 (UMLS CUI [1,1])
C0012546 (UMLS CUI [1,2])
C0039614 (UMLS CUI [1,3])
C0043167 (UMLS CUI [1,4])
exposure (to) disease diphtheria tetanus pertussis
Item
Known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, Hib and/or meningococcal serogroup C or Y disease within the last 3 months.
boolean
C0848543 (UMLS CUI [1,1])
C0012546 (UMLS CUI [1,2])
C0039614 (UMLS CUI [1,3])
C0043167 (UMLS CUI [1,4])
immunodeficient condition HIV infection
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C3829792 (UMLS CUI [1,1])
C0019693 (UMLS CUI [1,2])
Congenital immunodeficiency disease
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0272229 (UMLS CUI [1])
Hypersensitivity
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1])
Chronic disease
Item
Major congenital defects or serious chronic illness.
boolean
C0008679 (UMLS CUI [1])
neurologic disorders seizures
Item
History of any neurologic disorders or seizures including febrile seizures in infancy.
boolean
C0027765 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
Acute disease diarrhoea respiratory infection
Item
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low- grade febrile illness, i.e., Axillary temperature <37.5°C / Rectal temperature <38°C)
boolean
C0001314 (UMLS CUI [1,1])
C0011991 (UMLS CUI [1,2])
C0035243 (UMLS CUI [1,3])
immunoglobulins
Item
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
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