ID

33018

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 CRF Seiten: 268-336; 870-938

Stichworte

Versionen (1)
  1. 23.11.18 23.11.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

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

Englisch

Visit 3: Study Continuation Check

1 Formulare  
Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Visit
Beschreibung

42-56 days after Visit 2

Datentyp

text

Check for Study Continuation
Beschreibung

Check for Study Continuation

Did the subject return for visit 3?
Beschreibung

Did the subject return for visit 3?

Datentyp

boolean

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

If YES, Same reason and decision as previous visit?

Datentyp

boolean

If Different reason, complete below
Beschreibung

If Different reason, complete below

Datentyp

text

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

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

Datentyp

text

If Other, please specify
Beschreibung

If Other, please specify

Datentyp

text

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

If Non-serious AE, please specify unsolicited AE Number

Datentyp

integer

if SAE, please specify SAE Number
Beschreibung

if SAE, please specify SAE Number

Datentyp

integer

Please Tick who took the decision to withdraw from continuation
Beschreibung

Please Tick who took the decision to withdraw from continuation

Datentyp

text

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Ähnliche Modelle

Visit 3: Study Continuation Check

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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