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

Mots-clés

  1. 23/11/2018 23/11/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

23 novembre 2018

DOI

Pour une demande vous connecter.

Licence

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

Visit 3: Study Continuation Check

Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Type de données

integer

Visit
Description

42-56 days after Visit 2

Type de données

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?

Type de données

boolean

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

If YES, Same reason and decision as previous visit?

Type de données

boolean

If Different reason, complete below
Description

If Different reason, complete below

Type de données

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.

Type de données

text

If Other, please specify
Description

If Other, please specify

Type de données

text

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

If Non-serious AE, please specify unsolicited AE Number

Type de données

integer

if SAE, please specify SAE Number
Description

if SAE, please specify SAE Number

Type de données

integer

Please Tick who took the decision to withdraw from continuation
Description

Please Tick who took the decision to withdraw from continuation

Type de données

text

Similar models

Visit 3: Study Continuation Check

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Visit
text
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
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
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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