ID

33094

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

  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

Diary Card: Temperature (All Groups)

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

Temperature (day 0 - day 14)
Beschrijving

Temperature (day 0 - day 14)

Route
Beschrijving

Route

Datatype

text

Fever
Beschrijving

definition

Datatype

text

Please record temperature daily from day 0 to day 14 after vaccination at bedtime
Beschrijving

If multiple measures on the same day, take the maximum value. Please keep always the same route

Datatype

text

Temperature Log
Beschrijving

Temperature Log

Episode Number
Beschrijving

Day 0 to Day 14

Datatype

integer

Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • °C
°C
Medical advice
Beschrijving

Medical advice

Datatype

boolean

Temperature (day 15 - day 42)
Beschrijving

Temperature (day 15 - day 42)

Please screen temperature daily from day 15 to 42 please use the temperature sensitive pad or thermometer.
Beschrijving

If fever is indicated, please take the child's temperature using a thermometer and report measurement below. If multiple measures on the same day, take the maximum value.

Datatype

text

Temperature Log
Beschrijving

Temperature Log

Day
Beschrijving

Day

Datatype

text

Fever
Beschrijving

Fever

Datatype

boolean

Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • °C
°C
Medical advice
Beschrijving

Medical advice

Datatype

boolean

Similar models

Diary Card: Temperature (All Groups)

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Item
Dose Number
text
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
Item Group
Temperature (day 0 - day 14)
Item
Route
text
Code List
Route
CL Item
Axillary (1)
CL Item
Rectal (2)
Item
Fever
text
Code List
Fever
CL Item
Axillary (>=37.5°C) (1)
CL Item
Rectal (>=38°C) (2)
Please record temperature daily from day 0 to day 14 after vaccination at bedtime
Item
Please record temperature daily from day 0 to day 14 after vaccination at bedtime
text
Item Group
Temperature Log
Episode Number
Item
Episode Number
integer
Temperature
Item
Temperature
float
Medical advice
Item
Medical advice
boolean
Item Group
Temperature (day 15 - day 42)
Please screen temperature daily from day 15 to 42 please use the temperature sensitive pad or thermometer.
Item
Please screen temperature daily from day 15 to 42 please use the temperature sensitive pad or thermometer.
text
Item Group
Temperature Log
Day
Item
Day
text
Fever
Item
Fever
boolean
Temperature
Item
Temperature
float
Medical advice
Item
Medical advice
boolean

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