ID

29182

Beschreibung

Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

Stichworte

Versionen (1)
  1. 04.03.18 04.03.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. März 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Infanrix Vaccine - 102038

Englisch

Elegibility Questionnaire

1 Formulare  
Elegibility Question
Beschreibung

Elegibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschreibung

Elegibility Question

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Subjects who 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
Beschreibung

Subject Compliance Behaviour

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
A male or female of 4 years old, that participated and completed all the visits of SB217744/070 and 217744/083 study.
Beschreibung

Gender, age, study participation status

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C2348568
Written informed consent obtained from the parent or guardian of the subject.
Beschreibung

informed consent

Datentyp

boolean

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

Medical history

Datentyp

boolean

Alias
UMLS CUI [1]
C0262926
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period
Beschreibung

Investigational product use

Datentyp

boolean

Alias
UMLS CUI [1]
C0304229
Administration of immunosuppressants or other immune-modifying drugs from birth (for corticosteroids, this will mean prednisone, or equivalent, ≥0,5mg/kg/day. Inhaled and topical steroids are allowed.
Beschreibung

immunosuppressants

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Beschreibung

immunoglobin use

Datentyp

boolean

Alias
UMLS CUI [1]
C0021022
Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose.
Beschreibung

vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Evidence of previous or intercurrent diphtheria, tetanus and pertussis disease.
Beschreibung

diphtheria, tetanus, pertussis

Datentyp

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0012546
UMLS CUI [3]
C0039614
UMLS CUI [4]
C0043167
Evidence of previous diphtheria, tetanus and pertussis vaccination at 4 years of age.
Beschreibung

diphtheria, tetanus and pertussis vaccination

Datentyp

boolean

Alias
UMLS CUI [1]
C0012559
History of seizures or progressive neurological disease.
Beschreibung

seizure |progressive neurological disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C1335499
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Beschreibung

immunodeficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0021051
Major congenital defects or serious chronic illness.
Beschreibung

major congenical defects or serious chronic illness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220810
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Beschreibung

Medical history of allergic disease

Datentyp

boolean

Alias
UMLS CUI [1]
C2106654
Acute febrile illness (rectal temperature of ≥ 38ºC) at the time of planned vaccination (warrants deferral of the vaccination pending recovery of the subject).
Beschreibung

fever

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
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Ähnliche Modelle

Elegibility Questionnaire

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Elegibility Question
C1516637 (UMLS CUI-1)
Elegibility Question
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Subject Compliance Behaviour
Item
Subjects who 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, study participation status
Item
A male or female of 4 years old, that participated and completed all the visits of SB217744/070 and 217744/083 study.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
informed consent
Item
Written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1])
Medical history
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0262926 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Investigational product use
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period
boolean
C0304229 (UMLS CUI [1])
immunosuppressants
Item
Administration of immunosuppressants or other immune-modifying drugs from birth (for corticosteroids, this will mean prednisone, or equivalent, ≥0,5mg/kg/day. Inhaled and topical steroids are allowed.
boolean
C0021081 (UMLS CUI [1])
immunoglobin use
Item
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
boolean
C0021022 (UMLS CUI [1])
vaccination
Item
Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose.
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
diphtheria, tetanus, pertussis
Item
Evidence of previous or intercurrent diphtheria, tetanus and pertussis disease.
boolean
C0262926 (UMLS CUI [1])
C0012546 (UMLS CUI [2])
C0039614 (UMLS CUI [3])
C0043167 (UMLS CUI [4])
diphtheria, tetanus and pertussis vaccination
Item
Evidence of previous diphtheria, tetanus and pertussis vaccination at 4 years of age.
boolean
C0012559 (UMLS CUI [1])
seizure |progressive neurological disease
Item
History of seizures or progressive neurological disease.
boolean
C0036572 (UMLS CUI [1])
C0027765 (UMLS CUI [2,1])
C1335499 (UMLS CUI [2,2])
immunodeficiency
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C0021051 (UMLS CUI [1])
major congenical defects or serious chronic illness
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])
Medical history of allergic disease
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
C2106654 (UMLS CUI [1])
fever
Item
Acute febrile illness (rectal temperature of ≥ 38ºC) at the time of planned vaccination (warrants deferral of the vaccination pending recovery of the subject).
boolean
C0015967 (UMLS CUI [1])
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