ID
35761
Beskrivning
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
Nyckelord
Versioner (3)
- 2019-03-20 2019-03-20 -
- 2019-03-20 2019-03-20 -
- 2021-09-27 2021-09-27 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
20 mars 2019
DOI
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Licens
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
Beskrivning
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Beskrivning
Demographics
Alias
- UMLS CUI-1
- C1704791
Beskrivning
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beskrivning
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2,1]
- C0005834
- UMLS CUI [2,2]
- C0948254
Beskrivning
Please complete only if different from visit date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
Beskrivning
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2240392
Beskrivning
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C2240392
- UMLS CUI [2,2]
- C2348235
Beskrivning
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Datatyp
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
Beskrivning
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
Datatyp
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
Beskrivning
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Beskrivning
Would the subject be willing to participate in a follow-up study?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0600109
Beskrivning
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0016441
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C0392360
Beskrivning
If Adverse Event or Serious Adverse Event, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2348235
Beskrivning
If other, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Beskrivning
Tracking Document - Reason for non participation
Alias
- UMLS CUI-1
- C3889409
- UMLS CUI-3
- C0558080
- UMLS CUI-4
- C0679823
- UMLS CUI-5
- C0392360
Beskrivning
Previous Subject Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348585
- UMLS CUI [1,2]
- C2242969
Beskrivning
first name family name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Please document reason for non participation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
Beskrivning
Subject not eligible - Please specify criteria that are not fulfilled
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1555471
- UMLS CUI [1,2]
- C3828770
- UMLS CUI [1,3]
- C2348235
Beskrivning
Subject eligible but not willing to participate due to adverse events, or serious adverse event,please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3846156
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1519255
Beskrivning
If other Reason for Subject not willing to participate, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1136454
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
If Subject died, Date of Death
Datatyp
date
Alias
- UMLS CUI [1]
- C1148348
Beskrivning
Date of contact
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Beskrivning
Investigator signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator Signature Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigator name
Datatyp
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])
C0948254 (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])