ID

33018

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 CRF Seiten: 268-336; 870-938

Nyckelord

Versioner (1)
  1. 2018-11-23 2018-11-23 -
Rättsinnehavare

GSK group of companies

Uppladdad den

23 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

Engelsk

Visit 3: Study Continuation Check

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Visit
Beskrivning

42-56 days after Visit 2

Datatyp

text

Check for Study Continuation
Beskrivning

Check for Study Continuation

Did the subject return for visit 3?
Beskrivning

Did the subject return for visit 3?

Datatyp

boolean

If YES, Same reason and decision as previous visit?
Beskrivning

If YES, Same reason and decision as previous visit?

Datatyp

boolean

If Different reason, complete below
Beskrivning

If Different reason, complete below

Datatyp

text

If no, please tick the ONE most appropriate reason and skip the following pages of this visit.
Beskrivning

If no, please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatyp

text

If Other, please specify
Beskrivning

If Other, please specify

Datatyp

text

If Non-serious AE, please specify unsolicited AE Number
Beskrivning

If Non-serious AE, please specify unsolicited AE Number

Datatyp

integer

if SAE, please specify SAE Number
Beskrivning

if SAE, please specify SAE Number

Datatyp

integer

Please Tick who took the decision to withdraw from continuation
Beskrivning

Please Tick who took the decision to withdraw from continuation

Datatyp

text

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Similar models

Visit 3: Study Continuation Check

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Visit
text
Visit
Code List
Visit
CL Item
Visit 3 (1)
Item Group
Check for Study Continuation
Did the subject return for visit 3?
Item
Did the subject return for visit 3?
boolean
If YES, Same reason and decision as previous visit?
Item
If YES, Same reason and decision as previous visit?
boolean
If Different reason, complete below
Item
If Different reason, complete below
text
Item
If no, please tick the ONE most appropriate reason and skip the following pages of this visit.
text
If no, please tick the ONE most appropriate reason and skip the following pages of this visit.
Code List
If no, please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
[SAE] Serious Adverse Event (complete the SAE form) (1)
CL Item
[AEX] Non-Serious adverse event (complete the Non-serious AE form) (2)
CL Item
Other (3)
If Other, please specify
Item
If Other, please specify
text
If Non-serious AE, please specify unsolicited AE Number
Item
If Non-serious AE, please specify unsolicited AE Number
integer
if SAE, please specify SAE Number
Item
if SAE, please specify SAE Number
integer
Item
Please Tick who took the decision to withdraw from continuation
text
Please Tick who took the decision to withdraw from continuation
Code List
Please Tick who took the decision to withdraw from continuation
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
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