Information:
Fel:
ID
29000
Beskrivning
A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) given as a booster at 18-24 months of age to pre-term children who have received a three-dose primary immunization course with the same vaccine in study 217744/090.
Nyckelord
Versioner (1)
- 2018-02-20 2018-02-20 -
Rättsinnehavare
GlaxoSmithKline (GSK)
Uppladdad den
20 februari 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) Study ID: 101518
Similar models
Study conclusion
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item
Did the subject experience any Serious Adverse Event during the study period ?
integer
C1519255 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
Code List
Did the subject experience any Serious Adverse Event during the study period ?
CL Item
No (1)
CL Item
Yes, Specify total number of SAE's: |__|__| (2)
Item
Did any elimination criteria become applicable during the study ?
integer
C0680251 (UMLS CUI [1])
CL Item
No (1)
CL Item
Yes, Specify: __________________________________________________ (2)
study subject withdrawal
Item
Was the subject withdrawn from study ?
boolean
C2348568 (UMLS CUI [1])
C0422727 (UMLS CUI [2])
C0422727 (UMLS CUI [2])
Item
Please tick the ONE most appropriate category for withdrawal.
text
C2348568 (UMLS CUI [1])
C0422727 (UMLS CUI [2])
C0422727 (UMLS CUI [2])
CL Item
Serious adverse event(complete the Serious Adverse Event form) Please specify SAE N°: |__|__| ((SAE))
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) ((AEX))
CL Item
Protocol violation, please specify:_________________________________________ ((PTV))
CL Item
Consent withdrawal, not due to an adverse event. ((CWS))
CL Item
Migrated / moved from the study area ((MIG))
CL Item
Lost to follow-up. ((LFU))
CL Item
Other, please specify: ____________________________________________ ((OTH))
CL Item
Please specify unsolicited AE N° (Unsol.): |__|__| or solicited AE code :|__|__| (Please specify unsolicited AE N° (Unsol.): |__|__| or solicited AE code :|__|__|)
Item
Please tick who took decision:
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator ([I])
CL Item
Parents/Guardians ([P])
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
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section. (1)
CL Item
Yes (2)
Investigators signature date
Item
Investigators signature date
date
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])