ID

33096

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

Keywords

Versions (1)
  1. 11/27/18 11/27/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 27, 2018

DOI

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License

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

English

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

1 forms  
Administrative data
Description

Administrative data

Dose Number
Description

Dose Number

Data type

text

Subject Number
Description

Subject Number

Data type

integer

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

fill the date below

Data type

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.
Description

If rash occurs, please also record the event below

Data type

text

Rash Episode
Description

Rash Episode

Rash Episode Number
Description

Rash Episode Number

Data type

integer

Description
Description

Description

Data type

text

Vaccination site
Description

Vaccination site

Data type

text

Date Started
Description

Date Started

Data type

date

Date Stopped
Description

Date Stopped

Data type

date

Intensity
Description

Intensity

Data type

text

Temperature
Description

Temperature

Data type

text

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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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