ID
43669
Descripción
Study ID: 100551 (EXT Y11) Clinical Study ID: 100551 Study Title: A double blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B vaccine when administered in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289770 Sponsor: GlaxoSmithKline Collaborators: N/A 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)
- 26/6/17 26/6/17 -
- 26/9/17 26/9/17 -
- 20/9/21 20/9/21 -
Subido en
20 de septiembre de 2021
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.
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 21 Year 14)
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 21 Year 14)
Descripción
General Information
Alias
- UMLS CUI-1
- C1508263
Descripción
Date of visit
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1320303
Descripción
Subject Number
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2348585
Descripción
I certify that Informed Consent has been obtained prior to any study procedure.
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0021430
Descripción
Demographics
Alias
- UMLS CUI-1
- C1704791
Descripción
Center number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Descripción
Date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Gender
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Race
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0034510
Descripción
Race: Specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C2348235
Descripción
Laboratory tests
Alias
- UMLS CUI-1
- C0022885
Descripción
Anti-HAV and anti-HBs antibodies
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0201473
- UMLS CUI [2]
- C0201478
Descripción
Collection Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1317250
Descripción
Hepatitis A or Hepatitis B vaccine
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2240392
Descripción
Hepatitis A or Hepatitis B vaccine: Specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C2240392
- UMLS CUI [2,2]
- C2348235
Descripción
Hepatitis A or Hepatitis B immunoglobulins
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3652495
- UMLS CUI [2]
- C0062525
Descripción
Specification of Hepatitis A or Hepatitis B immunoglobulins
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C0062525
- UMLS CUI [2,2]
- C2348235
Descripción
Hepatitis A or B infection
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0019159
- UMLS CUI [2]
- C0019163
Descripción
Serology conclusion before booster
Alias
- UMLS CUI-1
- C0036743
Descripción
Please complete this section only after receipt of the serology results related to the assessment done at visit 21.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0201478
Descripción
If YES to any of above, subject will receive either ENGERIX™, HAVRIX™ or TWINRIX™ ADULT as appropriate. Please complete the entire Case Report Form. If NO to both questions, please complete the study conclusion section only.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0062524
Similar models
Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 21 Year 14)
C0579004 (UMLS CUI-2)
C0600091 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0201478 (UMLS CUI [2])
C2240392 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C2240392 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0062525 (UMLS CUI [2])
C2348235 (UMLS CUI [1,2])
C0062525 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0019163 (UMLS CUI [2])