ID

33082

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

Mots-clés

Versions (1)
  1. 26/11/2018 26/11/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

26 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

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Non-Serious Adverse Event Form

1 Formulaires  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Type de données

integer

Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Has any non-serious adverse events occurred within minimum 43 days post-vaccination?
Description

Please exclude those recorded on the SAE form

Type de données

boolean

If Yes, please complete the following table
Description

If Yes, please complete the following table

Type de données

text

AE Details
Description

AE Details

AE Number
Description

AE Number

Type de données

integer

Description
Description

Description

Type de données

text

Administration sites
Description

Administration sites

Type de données

text

Date started
Description

Date started

Type de données

date

Date stopped
Description

Date stopped

Type de données

date

Intensity
Description

Intensity

Type de données

text

Relationship to investigational products
Description

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Type de données

boolean

Outcome
Description

Outcome

Type de données

text

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Similar models

Non-Serious Adverse Event Form

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Non-Serious Adverse Events
Has any non-serious adverse events occurred within minimum 43 days post-vaccination?
Item
Has any non-serious adverse events occurred within minimum 43 days post-vaccination?
boolean
If Yes, please complete the following table
Item
If Yes, please complete the following table
text
Item Group
AE Details
Item
AE Number
integer
AE Number
Code List
AE Number
CL Item
Event 1 (1)
CL Item
Event 2 (2)
CL Item
Event 3 (3)
CL Item
Event 4 (4)
Description
Item
Description
text
Item
Administration sites
text
Administration sites
Code List
Administration sites
CL Item
MeMuRu-OKA vaccine (1)
CL Item
Priorix vaccine (2)
CL Item
Varilrix vaccine (3)
CL Item
Non-administration site (4)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational products
Item
Relationship to investigational products
boolean
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ Not resolved (3)
CL Item
Recovered with sequelae/ Resolved with sequelae (4)
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