ID

35691

Descripción

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Palabras clave

  1. 15/3/19 15/3/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

15 de marzo de 2019

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.

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.

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)

Visit 2, 3 and 5 - Laboratory Tests

Administration
Descripción

Administration

Alias
UMLS CUI-1
C1320722
Visit
Descripción

Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Laboratory Tests - Visit 2
Descripción

Laboratory Tests - Visit 2

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0545082
Has a blood sample been taken ?
Descripción

Has a blood sample been taken ?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834
Laboratory Tests - Visit 3
Descripción

Laboratory Tests - Visit 3

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0545082
Has a blood sample been taken ?
Descripción

Has a blood sample been taken ?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834
Laboratory Tests - Visit 5
Descripción

Laboratory Tests - Visit 5

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0545082
Has a blood sample been taken ?
Descripción

Subjects who fail to exhibit a satisfactory immune response following the two-dose candidate vaccine course, as evidenced by anti-HBs titre ≥ 10mIU/ml and/or seropositivity for anti-HAV, will be p rovided an additional dose of the appropriate commercial vaccine.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834

Similar models

Visit 2, 3 and 5 - Laboratory Tests

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Visit
Item
Visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Laboratory Tests - Visit 2
C0022885 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Has a blood sample been taken ?
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
Item Group
Laboratory Tests - Visit 3
C0022885 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Has a blood sample been taken ?
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
Item Group
Laboratory Tests - Visit 5
C0022885 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Has a blood sample been taken ?
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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