ID

33018

Descrição

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

Palavras-chave

Versões (1)
  1. 23/11/2018 23/11/2018 -
Titular dos direitos

GSK group of companies

Transferido a

23 novembre 2018

DOI

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Licença

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

Inglês

Visit 3: Study Continuation Check

1 Formulários  
Administrative data
Descrição

Administrative data

Subject Number
Descrição

Subject Number

Tipo de dados

integer

Visit
Descrição

42-56 days after Visit 2

Tipo de dados

text

Check for Study Continuation
Descrição

Check for Study Continuation

Did the subject return for visit 3?
Descrição

Did the subject return for visit 3?

Tipo de dados

boolean

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

If YES, Same reason and decision as previous visit?

Tipo de dados

boolean

If Different reason, complete below
Descrição

If Different reason, complete below

Tipo de dados

text

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

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

Tipo de dados

text

If Other, please specify
Descrição

If Other, please specify

Tipo de dados

text

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

If Non-serious AE, please specify unsolicited AE Number

Tipo de dados

integer

if SAE, please specify SAE Number
Descrição

if SAE, please specify SAE Number

Tipo de dados

integer

Please Tick who took the decision to withdraw from continuation
Descrição

Please Tick who took the decision to withdraw from continuation

Tipo de dados

text

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Similar models

Visit 3: Study Continuation Check

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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