ID

35932

Beschreibung

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

Stichworte

Versionen (3)
  1. 20.03.19 20.03.19 -
  2. 04.04.19 04.04.19 -
  3. 20.09.21 20.09.21 -
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GlaxoSmithKline

Hochgeladen am

4. April 2019

DOI

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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)

Englisch

Long-Term Follow-Up (Visit 13, Year 10) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion Before Booster

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Beschreibung

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Beschreibung

I certify that Informed Consent has been obtained prior to any study procedure.

Datentyp

date

Alias
UMLS CUI [1]
C2985782
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
Center Number
Beschreibung

Center Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Laboratory Tests
Beschreibung

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Beschreibung

Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0201473
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0948254
Date blood sample taken
Beschreibung

Please complete only if different from visit date

Datentyp

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Beschreibung

Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C2240392
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
Beschreibung

If subject has received Hepatitis A or Hepatitis B vaccine, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C2240392
UMLS CUI [2,2]
C2348235
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Beschreibung

Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?

Datentyp

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
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
Beschreibung

If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.

Datentyp

integer

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0062525
UMLS CUI [2,2]
C2348235
Serology Conclusion Before Booster
Beschreibung

Serology Conclusion Before Booster

Alias
UMLS CUI-1
C0036743
UMLS CUI-2
C1707478
UMLS CUI-3
C0419739
UMLS CUI-4
C0419731
Has the subject lost HBs antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948254
UMLS CUI [1,2]
C2348792
Has the subject lost HAV antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201473
UMLS CUI [1,2]
C2348792
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Ähnliche Modelle

Long-Term Follow-Up (Visit 13, Year 10) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion Before Booster

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (F)
CL Item
Male (M)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C0005834 (UMLS CUI [1,1])
C0201473 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0948254 (UMLS CUI [2,2])
Date blood sample taken
Item
Date blood sample taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Item
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
boolean
C0170300 (UMLS CUI [1,1])
C2240392 (UMLS CUI [1,2])
Item
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
integer
C0170300 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2240392 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
Code List
If subject has received Hepatitis A or Hepatitis B vaccine, please specify
CL Item
Hepatitis A vaccine (1)
CL Item
Hepatitis B vaccine (2)
CL Item
Combined Hepatitis A and B vaccine (3)
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Item
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
boolean
C3652495 (UMLS CUI [1,1])
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])
Item
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
integer
C3652495 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0062525 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
undefined item
Code List
If the subject received Hepatitis A or Hepatitis B immunoglobulins since the last visit, please specify.
CL Item
Hepatitis A immunoglobulins (1)
CL Item
Hepatitis B immunoglobulins (2)
Item Group
Serology Conclusion Before Booster
C0036743 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
C0419739 (UMLS CUI-3)
C0419731 (UMLS CUI-4)
Has the subject lost HBs antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10?
Item
Has the subject lost HBs antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
boolean
C0948254 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Has the subject lost HAV antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10?
Item
Has the subject lost HAV antibodies at any of the 4 following time points: Y6 or Y7or Y8or Y9 or Y10 (= visit 13 included)?
boolean
C0201473 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
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