Informatie:
Fout:
ID
29182
Beschrijving
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.
Trefwoorden
Versies (1)
- 04-03-18 04-03-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 maart 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Infanrix Vaccine - 102038
Elegibility Questionnaire
- StudyEvent: ODM
Similar models
Elegibility Questionnaire
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Elegibility Question
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (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])
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])
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])
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])
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])
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])
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])