ID
33084
Beskrivning
Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella
Nyckelord
Versioner (1)
- 2018-11-26 2018-11-26 -
Rättsinnehavare
GSK group of companies
Uppladdad den
26 november 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020
Study Conclusion Form
- StudyEvent: ODM
Beskrivning
Occurrence of Serious Adverse Event
Beskrivning
Did the subject experience any Serious Adverse Events during the study period?
Datatyp
boolean
Beskrivning
If Yes, please specify total number of SAE's
Datatyp
integer
Beskrivning
Status of treatment blind
Beskrivning
For the control group, please tick 'No'
Datatyp
boolean
Beskrivning
If Yes, please complete date
Datatyp
date
Beskrivning
Check the reason of blind breach
Datatyp
integer
Beskrivning
complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate
Datatyp
text
Beskrivning
Elimination Criteria
Beskrivning
Did any elimination criteria become applicable during the study?
Datatyp
boolean
Beskrivning
If Yes, specify
Datatyp
text
Beskrivning
Was the subject withdrawn from study?
Datatyp
boolean
Beskrivning
If Yes, please tick the ONE most appropriate category for withdrawal
Datatyp
text
Beskrivning
If SAE, please specify SAE Number
Datatyp
integer
Beskrivning
If Non-SAE please specify unsolicited AE Number
Datatyp
integer
Beskrivning
If Protocol violation, please specify
Datatyp
text
Beskrivning
If Other, please specify
Datatyp
text
Beskrivning
Please tick who took decision
Datatyp
text
Beskrivning
Date of last contact
Datatyp
date
Beskrivning
Was the subject in good condition at date of last contact?
Datatyp
text
Beskrivning
Investigator's Signature
Beskrivning
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my collegues is, to the best of my knowledge, complete and accurate, as of the date below.
Datatyp
date
Beskrivning
Investigator's signature
Datatyp
text
Beskrivning
Printed Investigator's name
Datatyp
text
Similar models
Study Conclusion Form
- StudyEvent: ODM