ID

33094

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

  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

Diary Card: Temperature (All Groups)

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

Temperature (day 0 - day 14)
Description

Temperature (day 0 - day 14)

Route
Description

Route

Data type

text

Fever
Description

definition

Data type

text

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

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

Data type

text

Temperature Log
Description

Temperature Log

Episode Number
Description

Day 0 to Day 14

Data type

integer

Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
°C
Medical advice
Description

Medical advice

Data type

boolean

Temperature (day 15 - day 42)
Description

Temperature (day 15 - day 42)

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

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.

Data type

text

Temperature Log
Description

Temperature Log

Day
Description

Day

Data type

text

Fever
Description

Fever

Data type

boolean

Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
°C
Medical advice
Description

Medical advice

Data type

boolean

Similar models

Diary Card: Temperature (All Groups)

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