ID

26603

Beschrijving

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

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Versies (1)
  1. 21-10-17 21-10-17 -
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GlaxoSmithKline

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21 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine Study Conclusion 101223

Engels

Study Conclusion

1 Formulieren  
  1. StudyEvent: ODM
    1. Study Conclusion
Follow-up Studies
Beschrijving

Follow-up Studies

Alias
UMLS CUI-1
C0016441
UMLS CUI-2
C0042210
Would the subject be willing to participate in a follow-up study?
Beschrijving

follow-up study

Datatype

boolean

Alias
UMLS CUI [1]
C0016441
No, please specify the most appropriate reason
Beschrijving

reason for non participation

Datatype

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Study conclusion
Beschrijving

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Did the subject experience any Serious Adverse Event during the study period ?
Beschrijving

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
If Yes, Specify total number of SAE's:
Beschrijving

number of SAEs

Datatype

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Was the treatment blind broken during the study?
Beschrijving

treatment blind

Datatype

boolean

Alias
UMLS CUI [1]
C3897431
treatment blind broken date
Beschrijving

If Yes, please specify

Datatype

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
reason treatment blind broken
Beschrijving

reason treatment blind broken

Datatype

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
reason treatment blind broken. If Other, please specify
Beschrijving

reason treatment blind broken

Datatype

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Did any elimination criteria become applicable during the study ?
Beschrijving

elimination criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
Did any elimination criteria become applicable during the study ? If Yes, please specify
Beschrijving

elimination criteria

Datatype

text

Alias
UMLS CUI [1]
C0680251
Was the subject withdrawn from study?
Beschrijving

subject withdrawn from study

Datatype

boolean

Alias
UMLS CUI [1]
C0422727
If Yes, Please tick the ONE most appropriate category for withdrawal.
Beschrijving

reason for withdrawal

Datatype

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Please tick who took decision
Beschrijving

withdraw decision

Datatype

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Date of last contact
Beschrijving

Date of last contact

Datatype

date

Alias
UMLS CUI [1,1]
C0805839
UMLS CUI [1,2]
C0011008
Was the subject in good condition at date of last contact?
Beschrijving

subject condition

Datatype

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Investigator's signature
Beschrijving

Investigator's signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Study Conclusion

1 Formulieren
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Follow-up Studies
C0016441 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
follow-up study
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1])
Item
No, please specify the most appropriate reason
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for non participation
Code List
No, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
number of SAEs
Item
If Yes, Specify total number of SAE's:
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
treatment blind
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
treatment blind broken date
Item
treatment blind broken date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
reason treatment blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason treatment blind broken
Code List
reason treatment blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (2)
reason treatment blind broken
Item
reason treatment blind broken. If Other, please specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
elimination criteria
Item
Did any elimination criteria become applicable during the study ?
boolean
C0680251 (UMLS CUI [1])
elimination criteria
Item
Did any elimination criteria become applicable during the study ? If Yes, please specify
text
C0680251 (UMLS CUI [1])
subject withdrawn from study
Item
Was the subject withdrawn from study?
boolean
C0422727 (UMLS CUI [1])
Item
If Yes, Please tick the ONE most appropriate category for withdrawal.
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason for withdrawal
Code List
If Yes, Please tick the ONE most appropriate category for withdrawal.
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Protocol violation (3)
CL Item
Consent withdrawal, not due to an adverse event (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
Item
Please tick who took decision
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
withdraw decision
Code List
Please tick who took decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
subject condition
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
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