ID
26603
Description
Study ID: 101223 Clinical Study ID: 101223 Study Title: Study to assess the lot-to-lot consistency of the production method of GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine and to compare to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine, when administered as a primary vaccination course. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Study Conclusion
Keywords
Versions (1)
- 10/21/17 10/21/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 21, 2017
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine Study Conclusion 101223
Study Conclusion
- StudyEvent: ODM
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Description
Serious Adverse Event
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
number of SAEs
Data type
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Description
treatment blind
Data type
boolean
Alias
- UMLS CUI [1]
- C3897431
Description
If Yes, please specify
Data type
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Description
reason treatment blind broken
Data type
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Description
reason treatment blind broken
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Description
elimination criteria
Data type
boolean
Alias
- UMLS CUI [1]
- C0680251
Description
elimination criteria
Data type
text
Alias
- UMLS CUI [1]
- C0680251
Description
subject withdrawn from study
Data type
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
reason for withdrawal
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Description
withdraw decision
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Description
Date of last contact
Data type
date
Alias
- UMLS CUI [1,1]
- C0805839
- UMLS CUI [1,2]
- C0011008
Description
subject condition
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Description
Investigator's signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Similar models
Study Conclusion
- StudyEvent: ODM
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])