ID

26177

Beskrivning

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: Visit 4, Month 5, 30-42 days after Visit 3

Nyckelord

Versioner (1)
  1. 2017-10-10 2017-10-10 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

10 oktober 2017

DOI

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Licens

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 Visit 4 101223

Engelsk

Visit 4 GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

1 Formulär  
Check for Study Continuation
Beskrivning

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C2240392
Did the subject return for visit 4 ?
Beskrivning

subject return for visit 4

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Beskrivning

If No, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
SAE Number
Beskrivning

If Serious adverse event, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE Number or Code
Beskrivning

If Non-serious adverse event, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Other reason for Study Discontinuation
Beskrivning

If Other, please specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
reason for study discontinuation
Beskrivning

reason for study discontinuation

Datatyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Laboratory tests
Beskrivning

Laboratory tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C2240392
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Has a blood sample been taken?
Beskrivning

Blood sample

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
Date blood sample was taken
Beskrivning

Collection Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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Similar models

Visit 4 GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine compared to GSK Biologicals' Tritanrix-HepB/Hiberix vaccine 101223

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C2240392 (UMLS CUI-3)
Item
Did the subject return for visit 4 ?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
subject come at visit 2
Code List
Did the subject return for visit 4 ?
CL Item
Yes, please complete the next pages. (1)
CL Item
No, please specify (2)
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for study discontinuation
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number or Code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Other reason for Study Discontinuation
Item
Other reason for Study Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for study discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for study discontinuation
Code List
reason for study discontinuation
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
C2240392 (UMLS CUI-2)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Collection Date
Item
Date blood sample was taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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