ID

23899

Description

Study part: Study Conclusion. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

Keywords

  1. 7/17/17 7/17/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 17, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Study Conclusion Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

Study Conclusion

  1. StudyEvent: ODM
    1. Study Conclusion
OCCURRENCE OF SERIOUS ADVERSE EVENT
Description

OCCURRENCE OF SERIOUS ADVERSE EVENT

Alias
UMLS CUI-1
C1519255
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Did the subject experience any Serious Adverse Event during the study period?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
If yes, please give the total number of SAE's:
Description

total number SAE

Data type

integer

Alias
UMLS CUI [1,1]
C4288115
UMLS CUI [1,2]
C1519255
STATUS OF TREATMENT BLIND
Description

STATUS OF TREATMENT BLIND

Alias
UMLS CUI-1
C2347797
UMLS CUI-2
C0039798
UMLS CUI-3
C2347038
Was the treatment blind broken during the study?
Description

Blinded Clinical Study

Data type

boolean

Alias
UMLS CUI [1]
C2347038
Date
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Reason
Description

reason

Data type

text

Alias
UMLS CUI [1]
C0392360
If other, please specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
ELIMINATION CRITERIA
Description

ELIMINATION CRITERIA

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable during the study?
Description

Elimination criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
If Yes, please specify:
Description

Elimination criteria

Data type

text

Alias
UMLS CUI [1]
C0680251
STUDY CONCLUSION
Description

STUDY CONCLUSION

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Was the subject withdrawn from study?
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Reason
Description

Reason

Data type

integer

Alias
UMLS CUI [1]
C0392360
If SAE, please specify SAE N° :
Description

SAE

Data type

text

Alias
UMLS CUI [1]
C1519255
If AEX, please specify AE N° (Unsol.) or code (Solicited) :
Description

Non-Serious adverse event

Data type

text

Alias
UMLS CUI [1]
C1518404
If (PTV) Protocol violation, please specify:
Description

Protocol violation

Data type

text

Alias
UMLS CUI [1]
C1709750
If (OTH) Other, please specify :
Description

(e.g. : consent withdrawal, Protocol violation, …)

Data type

text

Alias
UMLS CUI [1]
C0205394
Investigator's decision
Description

Investigator desicion study discontinuation

Data type

boolean

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C2826233
Parents/Guardian’s decision
Description

Parents desicion study discontinuation

Data type

boolean

Alias
UMLS CUI [1,1]
C0030551
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C2826233
Date of last contact:
Description

Date of last contact

Data type

date

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

medical condition contact last

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C1517741
INVESTIGATOR'S SIGNATURE
Description

INVESTIGATOR'S SIGNATURE

Alias
UMLS CUI-1
C2346576
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.
Description

confirmation

Data type

boolean

Alias
UMLS CUI [1]
C0750484
Investigator's signature:
Description

Investigators signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name:
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date:
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008

Similar models

Study Conclusion

  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
OCCURRENCE OF SERIOUS ADVERSE EVENT
C1519255 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
total number SAE
Item
If yes, please give the total number of SAE's:
integer
C4288115 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
STATUS OF TREATMENT BLIND
C2347797 (UMLS CUI-1)
C0039798 (UMLS CUI-2)
C2347038 (UMLS CUI-3)
Blinded Clinical Study
Item
Was the treatment blind broken during the study?
boolean
C2347038 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Reason
text
C0392360 (UMLS CUI [1])
Code List
Reason
CL Item
Medical emergency requiring identification of investigational product for further treatments (Medical emergency requiring identification of investigational product for further treatments)
CL Item
Other (Other)
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
Item Group
ELIMINATION CRITERIA
C0680251 (UMLS CUI-1)
Elimination criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
Elimination criteria
Item
If Yes, please specify:
text
C0680251 (UMLS CUI [1])
Item Group
STUDY CONCLUSION
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
study subject participation status
Item
Was the subject withdrawn from study?
boolean
C2348568 (UMLS CUI [1])
Item
Reason
integer
C0392360 (UMLS CUI [1])
Code List
Reason
CL Item
SAE Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
AEX Non-Serious adverse event (complete the Non-serious Adverse Event page) (2)
CL Item
PTV Protocol violation (3)
CL Item
CWS Consent withdrawal, not due to an adverse event. (4)
CL Item
MIG Migrated / moved from the study area (5)
CL Item
LFU Lost to follow-up. (6)
CL Item
OTH Other (7)
SAE
Item
If SAE, please specify SAE N° :
text
C1519255 (UMLS CUI [1])
Non-Serious adverse event
Item
If AEX, please specify AE N° (Unsol.) or code (Solicited) :
text
C1518404 (UMLS CUI [1])
Protocol violation
Item
If (PTV) Protocol violation, please specify:
text
C1709750 (UMLS CUI [1])
other
Item
If (OTH) Other, please specify :
text
C0205394 (UMLS CUI [1])
Investigator desicion study discontinuation
Item
Investigator's decision
boolean
C0008961 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C2826233 (UMLS CUI [1,3])
Parents desicion study discontinuation
Item
Parents/Guardian’s decision
boolean
C0030551 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C2826233 (UMLS CUI [1,3])
Date of last contact
Item
Date of last contact:
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
text
C0012634 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section (No, please give details within the Adverse Events section)
CL Item
Yes (Yes)
Item Group
INVESTIGATOR'S SIGNATURE
C2346576 (UMLS CUI-1)
confirmation
Item
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.
boolean
C0750484 (UMLS CUI [1])
Investigators signature
Item
Investigator's signature:
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Printed Investigator's name:
text
C2826892 (UMLS CUI [1])
Date
Item
Date:
date
C0011008 (UMLS CUI [1])

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