ID

33096

Beschrijving

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

Trefwoorden

Versies (1)
  1. 27-11-18 27-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

27 november 2018

DOI

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Licentie

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

Engels

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

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Dose Number
Beschrijving

Dose Number

Datatype

text

Subject Number
Beschrijving

Subject Number

Datatype

integer

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

fill the date below

Datatype

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.
Beschrijving

If rash occurs, please also record the event below

Datatype

text

Rash Episode
Beschrijving

Rash Episode

Rash Episode Number
Beschrijving

Rash Episode Number

Datatype

integer

Description
Beschrijving

Description

Datatype

text

Vaccination site
Beschrijving

Vaccination site

Datatype

text

Date Started
Beschrijving

Date Started

Datatype

date

Date Stopped
Beschrijving

Date Stopped

Datatype

date

Intensity
Beschrijving

Intensity

Datatype

text

Temperature
Beschrijving

Temperature

Datatype

text

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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Item
Dose Number
text
Dose Number
Code List
Dose Number
CL Item
Dose 1 (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
Rash Episode Number
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
Vaccination site
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
Intensity
Code List
Intensity
CL Item
1-50 lesions (1)
CL Item
51-150 lesions (2)
CL Item
>150 lesions (3)
Item
Temperature
text
Temperature
Code List
Temperature
CL Item
Please complete the Temperature diary card (1)
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