ID
33084
Beschreibung
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
Stichworte
Versionen (1)
- 26.11.18 26.11.18 -
Rechteinhaber
GSK group of companies
Hochgeladen am
26. November 2018
DOI
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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
Beschreibung
Occurrence of Serious Adverse Event
Beschreibung
Did the subject experience any Serious Adverse Events during the study period?
Datentyp
boolean
Beschreibung
If Yes, please specify total number of SAE's
Datentyp
integer
Beschreibung
Status of treatment blind
Beschreibung
For the control group, please tick 'No'
Datentyp
boolean
Beschreibung
If Yes, please complete date
Datentyp
date
Beschreibung
Check the reason of blind breach
Datentyp
integer
Beschreibung
complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate
Datentyp
text
Beschreibung
Elimination Criteria
Beschreibung
Did any elimination criteria become applicable during the study?
Datentyp
boolean
Beschreibung
If Yes, specify
Datentyp
text
Beschreibung
Was the subject withdrawn from study?
Datentyp
boolean
Beschreibung
If Yes, please tick the ONE most appropriate category for withdrawal
Datentyp
text
Beschreibung
If SAE, please specify SAE Number
Datentyp
integer
Beschreibung
If Non-SAE please specify unsolicited AE Number
Datentyp
integer
Beschreibung
If Protocol violation, please specify
Datentyp
text
Beschreibung
If Other, please specify
Datentyp
text
Beschreibung
Please tick who took decision
Datentyp
text
Beschreibung
Date of last contact
Datentyp
date
Beschreibung
Was the subject in good condition at date of last contact?
Datentyp
text
Beschreibung
Investigator's Signature
Beschreibung
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.
Datentyp
date
Beschreibung
Investigator's signature
Datentyp
text
Beschreibung
Printed Investigator's name
Datentyp
text
Ähnliche Modelle
Study Conclusion Form
- StudyEvent: ODM