ID
33084
Description
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
Keywords
Versions (1)
- 11/26/18 11/26/18 -
Copyright Holder
GSK group of companies
Uploaded on
November 26, 2018
DOI
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License
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
Description
Occurrence of Serious Adverse Event
Description
Did the subject experience any Serious Adverse Events during the study period?
Data type
boolean
Description
If Yes, please specify total number of SAE's
Data type
integer
Description
Status of treatment blind
Description
For the control group, please tick 'No'
Data type
boolean
Description
If Yes, please complete date
Data type
date
Description
Check the reason of blind breach
Data type
integer
Description
complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate
Data type
text
Description
Elimination Criteria
Description
Did any elimination criteria become applicable during the study?
Data type
boolean
Description
If Yes, specify
Data type
text
Description
Was the subject withdrawn from study?
Data type
boolean
Description
If Yes, please tick the ONE most appropriate category for withdrawal
Data type
text
Description
If SAE, please specify SAE Number
Data type
integer
Description
If Non-SAE please specify unsolicited AE Number
Data type
integer
Description
If Protocol violation, please specify
Data type
text
Description
If Other, please specify
Data type
text
Description
Please tick who took decision
Data type
text
Description
Date of last contact
Data type
date
Description
Was the subject in good condition at date of last contact?
Data type
text
Description
Investigator's Signature
Description
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.
Data type
date
Description
Investigator's signature
Data type
text
Description
Printed Investigator's name
Data type
text
Similar models
Study Conclusion Form
- StudyEvent: ODM