ID

33101

Beskrivning

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

Nyckelord

  1. 2018-11-27 2018-11-27 -
Rättsinnehavare

GSK group of companies

Uppladdad den

27 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

Diary Card: Rash/Exanthem + Parotid/Salivary gland swelling + Febrile Convulsions - Dose 2

Administrative data
Beskrivning

Administrative data

Dose Number
Beskrivning

Dose Number

Datatyp

text

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Please do not forget to bring back the diary card on
Beskrivning

fill the date below

Datatyp

date

In case rash/exanthem or Parotid/Salivary gland swelling or Febrile convulsions (suspected signs of meningism) is observed, bring the child to visit the investigators for clinical examination.
Beskrivning

If rash occurs, please also record the event below

Datatyp

text

Rash Episode
Beskrivning

Rash Episode

Rash Episode Number
Beskrivning

Rash Episode Number

Datatyp

integer

Description
Beskrivning

Description

Datatyp

text

Vaccination site
Beskrivning

Vaccination site

Datatyp

text

Date Started
Beskrivning

Date Started

Datatyp

date

Date Stopped
Beskrivning

Date Stopped

Datatyp

date

Intensity
Beskrivning

Intensity

Datatyp

text

Temperature
Beskrivning

Temperature

Datatyp

text

Similar models

Diary Card: Rash/Exanthem + Parotid/Salivary gland swelling + Febrile Convulsions - Dose 2

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Item
Dose Number
text
Code List
Dose Number
CL Item
Dose 2 (1)
Subject Number
Item
Subject Number
integer
Please do not forget to bring back the diary card on
Item
Please do not forget to bring back the diary card on
date
In case rash/exanthem or Parotid/Salivary gland swelling or Febrile convulsions (suspected signs of meningism) is observed, bring the child to visit the investigators for clinical examination.
Item
In case rash/exanthem or Parotid/Salivary gland swelling or Febrile convulsions (suspected signs of meningism) is observed, bring the child to visit the investigators for clinical examination.
text
Item Group
Rash Episode
Item
Rash Episode Number
integer
Code List
Rash Episode Number
CL Item
RA 1 (1)
CL Item
RA 2 (2)
CL Item
RA 3 (3)
Description
Item
Description
text
Item
Vaccination site
text
Code List
Vaccination site
CL Item
Left arm (1)
CL Item
Right arm (2)
CL Item
Non-administration site (3)
Date Started
Item
Date Started
date
Date Stopped
Item
Date Stopped
date
Item
Intensity
text
Code List
Intensity
CL Item
1-50 lesions (1)
CL Item
51-150 lesions (2)
CL Item
>150 lesions (3)
Item
Temperature
text
Code List
Temperature
CL Item
Please complete the Temperature diary card (1)

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