ID
32998
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 CRF Seiten: 268-336; 870-938
Keywords
Versions (2)
- 11/23/18 11/23/18 -
- 11/23/18 11/23/18 -
Copyright Holder
GSK group of companies
Uploaded on
November 23, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Immogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020
Vaccine Administration (Group Priorix+Varilrix)
- StudyEvent: ODM
Description
Vaccine Administration
Description
Vaccine
Description
Only one box must be ticked by vaccine
Data type
text
Description
if Replacement vial, record number
Data type
integer
Description
If Wrong vial number, please record the correct one
Data type
integer
Description
Side/ Site/ Route
Description
Administration according to Protocol
Description
Has the study vaccine been administered according to protocol?
Data type
boolean
Description
If No, please tick all items that apply: Side
Data type
integer
Description
Site
Data type
text
Description
Route
Data type
text
Description
Comment
Data type
text
Description
Vaccine 2
Description
Only one box must be ticked by vaccine 2
Data type
text
Description
if Replacement vial, record number
Data type
integer
Description
If Wrong vial number, please record the correct one
Data type
integer
Description
Side/ Site/ Route
Description
Administration according to Protocol
Description
Has the study vaccine been administered according to protocol?
Data type
boolean
Description
If No, please tick all items that apply: Side
Data type
integer
Description
Site
Data type
text
Description
Route
Data type
text
Description
Comment
Data type
text
Description
Non administration
Description
Please tick the ONE most appropriate category for non-administration
Data type
text
Description
If SAE, record the event number
Data type
integer
Description
If Non-SAE, record the event number
Data type
integer
Description
e.g., consent withdrawal, protocol violation, etc
Data type
text
Description
Please tick who took the decision
Data type
text
Description
Immediate Post-Vaccination Observation
Description
If any adverse events occurred during the immediate post-vaccination time (30 min), fill in the SAE or Non-SAE form.
Data type
text
Description
Any other vaccines administered must be recorded in the Concomitant Vaccination form
Data type
text
Similar models
Vaccine Administration (Group Priorix+Varilrix)
- StudyEvent: ODM