ID
44569
Description
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
Mots-clés
Versions (3)
- 20/03/2019 20/03/2019 -
- 20/03/2019 20/03/2019 -
- 27/09/2021 27/09/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
27 septembre 2021
DOI
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Licence
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 10, Year 7) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document
Description
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Description
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2,1]
- C0005834
- UMLS CUI [2,2]
- C0201478
Description
Please complete only if different from visit date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
Description
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2240392
Description
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C2240392
- UMLS CUI [2,2]
- C2348235
Description
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Type de données
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
Description
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
Type de données
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
Description
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Description
Would the subject be willing to participate in a follow-up study?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
Description
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C0392360
Description
If Adverse Event or Serious Adverse Event, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2348235
Description
If other, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Description
Tracking Document - Reason for non participation
Alias
- UMLS CUI-1
- C3889409
- UMLS CUI-3
- C0558080
- UMLS CUI-4
- C0679823
- UMLS CUI-5
- C0392360
Description
Previous Subject Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C2242969
Description
first name family name
Type de données
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
Description
Date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Please document reason for non participation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Description
Subject not eligible - Please specify criteria that are not fulfilled
Type de données
text
Alias
- UMLS CUI [1,1]
- C1555471
- UMLS CUI [1,2]
- C3828770
- UMLS CUI [1,3]
- C2348235
Description
Subject eligible but not willing to participate due to adverse events, or serious adverse event,please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C3846156
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1519255
Description
If other Reason for Subject not willing to participate, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1136454
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
If Subject died, Date of Death
Type de données
date
Alias
- UMLS CUI [1]
- C1148348
Description
Date of contact
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Description
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Description
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.
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator Signature Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Long-Term Follow-Up (Visit 10, Year 7) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document
C0600091 (UMLS CUI [1,2])
C0201473 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0201478 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C2240392 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C2240392 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
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])
C0019080 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0062525 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
C0600109 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C0558080 (UMLS CUI-3)
C0679823 (UMLS CUI-4)
C0392360 (UMLS CUI-5)
C2242969 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C3828770 (UMLS CUI [1,2])
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])