ID

33101

Descrizione

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

  1. 27-11-18 27-11-18 -
Titolare del copyright

GSK group of companies

Caricato su

27 november 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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
Descrizione

Administrative data

Dose Number
Descrizione

Dose Number

Tipo di dati

text

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

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

fill the date below

Tipo di dati

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.
Descrizione

If rash occurs, please also record the event below

Tipo di dati

text

Rash Episode
Descrizione

Rash Episode

Rash Episode Number
Descrizione

Rash Episode Number

Tipo di dati

integer

Description
Descrizione

Description

Tipo di dati

text

Vaccination site
Descrizione

Vaccination site

Tipo di dati

text

Date Started
Descrizione

Date Started

Tipo di dati

date

Date Stopped
Descrizione

Date Stopped

Tipo di dati

date

Intensity
Descrizione

Intensity

Tipo di dati

text

Temperature
Descrizione

Temperature

Tipo di dati

text

Similar models

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

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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