ID

25552

Beskrivning

Study Conclusion form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A 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)
  1. 2017-08-29 2017-08-29 -
  2. 2017-09-01 2017-09-01 -
  3. 2017-09-05 2017-09-05 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

5 september 2017

DOI

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Creative Commons BY-NC 3.0
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Study Conclusion Biologicals HepA/HepB vaccine 208127/125

Engelsk

Study Conclusion Biologicals HepA/HepB vaccine 208127/125

1 Formulär  
Header
Beskrivning

Header

Alias
UMLS CUI-1
C1320722
Protocol
Beskrivning

Protocol

Datatyp

text

Alias
UMLS CUI [1]
C1507394
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Study Conclusion
Beskrivning

Study Conclusion

Has the code been broken ?
Beskrivning

Randomization revealed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0443289
not applicable in case of an open study/a single-blind study
Beskrivning

Has the code been broken ? NA = not applicable

Datatyp

boolean

Alias
UMLS CUI [1]
C1272460
If yes, please comment :
Beskrivning

Code has been broken

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Did the subject complete the study according to the protocol ? (excluding non-observance of the time intervals as these will be verified by SB later on)
Beskrivning

if No, mark the ONE most appropriate category and comment below

Datatyp

boolean

Alias
UMLS CUI [1]
C2348577
Adverse Experience (complete the Adverse Experience Section)
Beskrivning

Mark the ONE most appropriate category and comment below

Datatyp

boolean

Alias
UMLS CUI [1]
C0559546
Protocol violation
Beskrivning

Mark the ONE most appropriate category and comment below

Datatyp

boolean

Alias
UMLS CUI [1]
C1709750
Consent withdrawal by the subject
Beskrivning

Mark the ONE most appropriate category and comment below

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1511481
Lost to follow-up
Beskrivning

Mark the ONE most appropriate category and comment below

Datatyp

boolean

Alias
UMLS CUI [1]
C1302313
Termination by SmithKline Beecham
Beskrivning

Mark the ONE most appropriate category and comment below

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2718058
UMLS CUI [1,2]
C0008961
Others, specify:
Beskrivning

Mark the ONE most appropriate category and comment below

Datatyp

text

Alias
UMLS CUI [1]
C3845569
Comments:
Beskrivning

Comments:

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Date of last contact :
Beskrivning

day/month/year

Datatyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Beskrivning

if No, please give details within the Adverse Experience Section

Datatyp

boolean

Alias
UMLS CUI [1]
C2051434
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Date :
Beskrivning

day/month/year

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Investigator Signature :
Beskrivning

I certify that I have reviewed the data in this case report form and that all information is complete and accurate.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Study Conclusion Biologicals HepA/HepB vaccine 208127/125

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol
Item
Protocol
text
C1507394 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Study Conclusion
Randomization revealed
Item
Has the code been broken ?
boolean
C0034656 (UMLS CUI [1,1])
C0443289 (UMLS CUI [1,2])
not applicable
Item
not applicable in case of an open study/a single-blind study
boolean
C1272460 (UMLS CUI [1])
Please comment
Item
If yes, please comment :
text
C0947611 (UMLS CUI [1])
Study completed
Item
Did the subject complete the study according to the protocol ? (excluding non-observance of the time intervals as these will be verified by SB later on)
boolean
C2348577 (UMLS CUI [1])
Adverse Experience
Item
Adverse Experience (complete the Adverse Experience Section)
boolean
C0559546 (UMLS CUI [1])
Protocol violation
Item
Protocol violation
boolean
C1709750 (UMLS CUI [1])
Consent withdrawal
Item
Consent withdrawal by the subject
boolean
C2349954 (UMLS CUI [1,1])
C1511481 (UMLS CUI [1,2])
Lost to follow-up
Item
Lost to follow-up
boolean
C1302313 (UMLS CUI [1])
Termination by investigator
Item
Termination by SmithKline Beecham
boolean
C2718058 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Others, specify:
Item
Others, specify:
text
C3845569 (UMLS CUI [1])
Comments:
Item
Comments:
text
C0947611 (UMLS CUI [1])
Date of last contact
Item
Date of last contact :
date
C0805839 (UMLS CUI [1])
Good condition
Item
Was the subject in good condition at date of last contact?
boolean
C2051434 (UMLS CUI [1])
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date
Item
Date :
date
C0011008 (UMLS CUI [1])
Signature
Item
Investigator Signature :
text
C2346576 (UMLS CUI [1])
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