ID
35762
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)
- 20/3/19 20/3/19 -
- 27/9/21 27/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de marzo de 2019
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 12, Year 9) - 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]
- C0948254
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
Did the Subject experience any SAE since Last Visit?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
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
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
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
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
If Subject died, Date of Death
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1148348
Descripción
Date of contact
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Descripción
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Descripción
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
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 12, Year 9) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document
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C2348235 (UMLS CUI [2,2])
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C2348235 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1136454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1705415 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])