ID

29182

Descripción

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.

Palabras clave

Versiones (1)
  1. 4/3/18 4/3/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de marzo de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Infanrix Vaccine - 102038

Inglés

Elegibility Questionnaire

1 formularios  
Elegibility Question
Descripción

Elegibility Question

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

Elegibility Question

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Descripción

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
Descripción

Subject Compliance Behaviour

Tipo de datos

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.
Descripción

Gender, age, study participation status

Tipo de datos

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.
Descripción

informed consent

Tipo de datos

boolean

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

Medical history

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262926
Exclusion Criteria
Descripción

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
Descripción

Investigational product use

Tipo de datos

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.
Descripción

immunosuppressants

Tipo de datos

boolean

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

immunoglobin use

Tipo de datos

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.
Descripción

vaccination

Tipo de datos

boolean

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

diphtheria, tetanus, pertussis

Tipo de datos

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.
Descripción

diphtheria, tetanus and pertussis vaccination

Tipo de datos

boolean

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

seizure |progressive neurological disease

Tipo de datos

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.
Descripción

immunodeficiency

Tipo de datos

boolean

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

major congenical defects or serious chronic illness

Tipo de datos

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.
Descripción

Medical history of allergic disease

Tipo de datos

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).
Descripción

fever

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015967
Volver a la parte superior de la página

Similar models

Elegibility Questionnaire

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial