ID
44555
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 (2)
- 18/3/19 18/3/19 -
- 27/9/21 27/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
27 de septiembre de 2021
DOI
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Licencia
Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)
Long-Term Follow-Up (Visit 9, Year 6) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document
Descripción
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Descripción
Demographics
Alias
- UMLS CUI-1
- C1704791
Descripción
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
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]
- C0201478
Descripción
Please complete only if different from visit date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
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
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
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
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]
- C0019080
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C2348235
- UMLS CUI [2,1]
- C0062525
- UMLS CUI [2,2]
- C0019080
- UMLS CUI [2,3]
- C0332152
- UMLS CUI [2,4]
- C2348235
Descripción
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Descripción
Would the subject be willing to participate in a follow-up study?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
Descripción
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C0392360
Descripción
If Adverse Event or Serious Adverse Event, please specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2348235
Descripción
If other, please specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Descripción
Tracking Document - Reason for non participation
Alias
- UMLS CUI-1
- C3889409
- UMLS CUI-3
- C0558080
- UMLS CUI-4
- C0679823
- UMLS CUI-5
- C0392360
Descripción
Previous Subject Number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C2242969
Descripción
first name family name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
Descripción
Date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Please document reason for non participation
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Descripción
Subject not eligible - Please specify criteria that are not fulfilled
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1555471
- UMLS CUI [1,2]
- C3828770
- UMLS CUI [1,3]
- C2348235
Descripción
If other Reason for Subject not willing to participate, please specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1136454
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Descripción
Date of contact
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Descripción
Subject eligible but not willing to participate due to adverse events, or serious adverse event,please specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3846156
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1519255
Descripción
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Descripción
Investigator Signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator Signature Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Investigator name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
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Long-Term Follow-Up (Visit 9, Year 6) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document
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C0332152 (UMLS CUI [1,3])
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C2348235 (UMLS CUI [2,4])
C0600109 (UMLS CUI [1,2])
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C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
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C2348235 (UMLS CUI [1,2])
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C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C3828770 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1136454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1705415 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])