ID
35932
Beschrijving
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
Trefwoorden
Versies (3)
- 20-03-19 20-03-19 -
- 04-04-19 04-04-19 -
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 april 2019
DOI
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Licentie
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 13, Year 10) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion Before Booster
Beschrijving
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Beschrijving
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschrijving
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2,1]
- C0005834
- UMLS CUI [2,2]
- C0948254
Beschrijving
Please complete only if different from visit date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
Beschrijving
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2240392
Beschrijving
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C2240392
- UMLS CUI [2,2]
- C2348235
Beschrijving
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Datatype
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
Beschrijving
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C0062525
- UMLS CUI [2,2]
- C2348235
Beschrijving
Serology Conclusion Before Booster
Alias
- UMLS CUI-1
- C0036743
- UMLS CUI-2
- C1707478
- UMLS CUI-3
- C0419739
- UMLS CUI-4
- C0419731
Beschrijving
If YES, subject will receive either ENGERIX™, HAVRIX™ or TWINRIX™ as appropriate. Please complete the entire Case Report Form. If NO to both questions, please complete the SAE section and study conclusion section only.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0948254
- UMLS CUI [1,2]
- C2348792
Beschrijving
If YES, subject will receive either ENGERIX™, HAVRIX™ or TWINRIX™ as appropriate. Please complete the entire Case Report Form. If NO to both questions, please complete the SAE section and study conclusion section only.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201473
- UMLS CUI [1,2]
- C2348792
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Long-Term Follow-Up (Visit 13, Year 10) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion Before Booster
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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])
C2348235 (UMLS CUI [1,2])
C0062525 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1707478 (UMLS CUI-2)
C0419739 (UMLS CUI-3)
C0419731 (UMLS CUI-4)
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])