ID

44570

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 (2)
  1. 20.03.19 20.03.19 -
  2. 27.09.21 27.09.21 -
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GlaxoSmithKline

Hochgeladen am

27. September 2021

DOI

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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 12, Year 9) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

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]
C0201478
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]
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
Follow-Up Studies
Beschreibung

Follow-Up Studies

Alias
UMLS CUI-1
C0016441
Would the subject be willing to participate in a follow-up study?
Beschreibung

Would the subject be willing to participate in a follow-up study?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0600109
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
Beschreibung

If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason

Datentyp

integer

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C0392360
If Adverse Event or Serious Adverse Event, please specify
Beschreibung

If Adverse Event or Serious Adverse Event, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C2348235
If other, please specify
Beschreibung

If other, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Did the Subject experience any SAE since Last Visit?
Beschreibung

Did the Subject experience any SAE since Last Visit?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1711239
Tracking Document - Reason for non participation
Beschreibung

Tracking Document - Reason for non participation

Alias
UMLS CUI-1
C3889409
UMLS CUI-3
C0558080
UMLS CUI-4
C0679823
UMLS CUI-5
C0392360
Previous Subject Number
Beschreibung

Previous Subject Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C2242969
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Please document reason for non participation
Beschreibung

Please document reason for non participation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Subject not eligible - Please specify criteria that are not fulfilled
Beschreibung

Subject not eligible - Please specify criteria that are not fulfilled

Datentyp

text

Alias
UMLS CUI [1,1]
C1555471
UMLS CUI [1,2]
C3828770
UMLS CUI [1,3]
C2348235
Subject eligible but not willing to participate due to adverse events, or serious adverse event, please specify
Beschreibung

Subject eligible but not willing to participate due to adverse events, or serious adverse event,please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C3846156
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1519255
If other Reason for Subject not willing to participate, please specify
Beschreibung

If other Reason for Subject not willing to participate, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1136454
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
If Subject died, Date of Death
Beschreibung

If Subject died, Date of Death

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Date of contact
Beschreibung

Date of contact

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Investigator signature
Beschreibung

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator Signature
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator name
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Long-Term Follow-Up (Visit 12, Year 9) - Informed Consent; Demographics; Laboratory Tests; Follow-Up Studies; Tracking Document

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])
C0201478 (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])
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])
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
Follow-Up Studies
C0016441 (UMLS CUI-1)
Would the subject be willing to participate in a follow-up study?
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
integer
C0016441 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
If subject would not be willing to participate in a follow-up study, please specify the reason
Code List
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
If Adverse Event or Serious Adverse Event, please specify
Item
If Adverse Event or Serious Adverse Event, please specify
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If other, please specify
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Did the Subject experience any SAE since Last Visit?
Item
Did the Subject experience any SAE since Last Visit?
boolean
C1519255 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
Item Group
Tracking Document - Reason for non participation
C3889409 (UMLS CUI-1)
C0558080 (UMLS CUI-3)
C0679823 (UMLS CUI-4)
C0392360 (UMLS CUI-5)
Previous Subject Number
Item
Previous Subject Number
integer
C2348585 (UMLS CUI [1,1])
C2242969 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Please document reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
Code List
Please document reason for non participation
CL Item
Subject not eligible - please specify criteria that are not fulfilled (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to adverse events, or serious adverse event or other (3)
CL Item
Subject died (4)
Subject not eligible - Please specify criteria that are not fulfilled
Item
Subject not eligible - Please specify criteria that are not fulfilled
text
C1555471 (UMLS CUI [1,1])
C3828770 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Subject eligible but not willing to participate due to adverse events, or serious adverse event,please specify
Item
Subject eligible but not willing to participate due to adverse events, or serious adverse event, please specify
text
C3846156 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If other Reason for Subject not willing to participate, please specify
Item
If other Reason for Subject not willing to participate, please specify
text
C0392360 (UMLS CUI [1,1])
C1136454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
If Subject died, Date of Death
Item
If Subject died, Date of Death
date
C1148348 (UMLS CUI [1])
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
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