ID

35932

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

Versiones (3)
  1. 20/3/19 20/3/19 -
  2. 4/4/19 4/4/19 -
  3. 20/9/21 20/9/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de abril 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.

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.

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

Inglés

Long-Term Follow-Up (Visit 13, Year 10) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion Before Booster

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Descripción

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Descripción

I certify that Informed Consent has been obtained prior to any study procedure.

Tipo de datos

date

Alias
UMLS CUI [1]
C2985782
Demographics
Descripción

Demographics

Alias
UMLS CUI-1
C1704791
Center Number
Descripción

Center Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Descripción

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Laboratory Tests
Descripción

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Descripción

Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0201473
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0948254
Date blood sample taken
Descripción

Please complete only if different from visit date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Descripción

Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C2240392
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
Descripción

If subject has received Hepatitis A or Hepatitis B vaccine, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C2240392
UMLS CUI [2,2]
C2348235
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Descripción

Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C0332152
UMLS CUI [2,1]
C0062525
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C0332152
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
Descripción

If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0062525
UMLS CUI [2,2]
C2348235
Serology Conclusion Before Booster
Descripción

Serology Conclusion Before Booster

Alias
UMLS CUI-1
C0036743
UMLS CUI-2
C1707478
UMLS CUI-3
C0419739
UMLS CUI-4
C0419731
Has the subject lost HBs antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
Descripción

If YES, subject will receive either ENGERIX™, HAVRIX™ or TWINRIX™ as appropriate. Please complete the entire Case Report Form. If NO to both questions, please complete the SAE section and study conclusion section only.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0948254
UMLS CUI [1,2]
C2348792
Has the subject lost HAV antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
Descripción

If YES, subject will receive either ENGERIX™, HAVRIX™ or TWINRIX™ as appropriate. Please complete the entire Case Report Form. If NO to both questions, please complete the SAE section and study conclusion section only.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0201473
UMLS CUI [1,2]
C2348792
Volver a la parte superior de la página

Similar models

Long-Term Follow-Up (Visit 13, Year 10) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion Before Booster

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (F)
CL Item
Male (M)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C0005834 (UMLS CUI [1,1])
C0201473 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0948254 (UMLS CUI [2,2])
Date blood sample taken
Item
Date blood sample taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Item
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
boolean
C0170300 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
Item
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
integer
C0170300 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2240392 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
Code List
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
CL Item
Hepatitis A vaccine (1)
CL Item
Hepatitis B vaccine (2)
CL Item
Combined Hepatitis A and B vaccine (3)
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Item
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
boolean
C3652495 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0062525 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
Item
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
integer
C3652495 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0062525 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
undefined item
Code List
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
CL Item
Hepatitis A immunoglobulins (1)
CL Item
Hepatitis B immunoglobulins (2)
Item Group
Serology Conclusion Before Booster
C0036743 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
C0419739 (UMLS CUI-3)
C0419731 (UMLS CUI-4)
Has the subject lost HBs antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10?
Item
Has the subject lost HBs antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
boolean
C0948254 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Has the subject lost HAV antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10?
Item
Has the subject lost HAV antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
boolean
C0201473 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
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