ID

33018

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 (1)
  1. 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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Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

English

Visit 3: Study Continuation Check

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Visit
Description

42-56 days after Visit 2

Data type

text

Check for Study Continuation
Description

Check for Study Continuation

Did the subject return for visit 3?
Description

Did the subject return for visit 3?

Data type

boolean

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

If YES, Same reason and decision as previous visit?

Data type

boolean

If Different reason, complete below
Description

If Different reason, complete below

Data type

text

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

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

Data type

text

If Other, please specify
Description

If Other, please specify

Data type

text

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

If Non-serious AE, please specify unsolicited AE Number

Data type

integer

if SAE, please specify SAE Number
Description

if SAE, please specify SAE Number

Data type

integer

Please Tick who took the decision to withdraw from continuation
Description

Please Tick who took the decision to withdraw from continuation

Data type

text

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Similar models

Visit 3: Study Continuation Check

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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