ID

33018

Descrizione

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

versioni (1)
  1. 23/11/18 23/11/18 -
Titolare del copyright

GSK group of companies

Caricato su

23 novembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Visit 3: Study Continuation Check

1 moduli  
Administrative data
Descrizione

Administrative data

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Visit
Descrizione

42-56 days after Visit 2

Tipo di dati

text

Check for Study Continuation
Descrizione

Check for Study Continuation

Did the subject return for visit 3?
Descrizione

Did the subject return for visit 3?

Tipo di dati

boolean

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

If YES, Same reason and decision as previous visit?

Tipo di dati

boolean

If Different reason, complete below
Descrizione

If Different reason, complete below

Tipo di dati

text

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

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

Tipo di dati

text

If Other, please specify
Descrizione

If Other, please specify

Tipo di dati

text

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

If Non-serious AE, please specify unsolicited AE Number

Tipo di dati

integer

if SAE, please specify SAE Number
Descrizione

if SAE, please specify SAE Number

Tipo di dati

integer

Please Tick who took the decision to withdraw from continuation
Descrizione

Please Tick who took the decision to withdraw from continuation

Tipo di dati

text

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Similar models

Visit 3: Study Continuation Check

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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