Information:
Fel:
ID
23899
Beskrivning
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
Nyckelord
Versioner (1)
- 2017-07-17 2017-07-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
17 juli 2017
DOI
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Licens
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
Similar models
Study Conclusion
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
C1519255 (UMLS CUI [1,2])
Item Group
STATUS OF TREATMENT BLIND
C2347797 (UMLS CUI-1)
C0039798 (UMLS CUI-2)
C2347038 (UMLS CUI-3)
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])
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])
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])
study subject participation status
Item
Was the subject withdrawn from study?
boolean
C2348568 (UMLS CUI [1])
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])
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])
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])
C0332158 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
CL Item
No, please give details within the Adverse Events section (No, please give details within the Adverse Events section)
CL Item
Yes (Yes)
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])