ID

33017

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 CRF Seiten: 268-336; 870-938

Keywords

Versions (1)
  1. 11/23/18 11/23/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 23, 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

Visit 2: Temperature Form

1 forms  
Post-Dose 2 Temperature
Description

Post-Dose 2 Temperature

Please record below all temperatures within 15 days post-vaccination
Description

If fever occurs after the solicited period, please complete the Non-SAE form; Complete Medication form for any antibiotics or antipyretics taken

Data type

text

Route
Description

Route

Data type

text

Temperature Log
Description

Temperature Log

Episode Number
Description

Episode Number

Data type

text

Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
°C
not taken
Description

not taken

Data type

text

If fever, Causality
Description

If fever, Causality

Data type

boolean

Medical advice
Description

Medical advice

Data type

boolean

Fever Screen
Description

Fever Screen

Day
Description

Day

Data type

text

Fever
Description

Fever (Axillary ≥ 37.5 °C; Rectal ≥ 38 °C)

Data type

text

If Yes, record Temperature
Description

If Yes, record Temperature

Data type

float

Measurement units
  • °C
°C
Causality
Description

Causality

Data type

boolean

Medical Advice
Description

Medical Advice

Data type

boolean

Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Visit
Description

Visit

Data type

text

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Similar models

Visit 2: Temperature Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Post-Dose 2 Temperature
Item
Please record below all temperatures within 15 days post-vaccination
text
Please record below all temperatures within 15 days post-vaccination
Code List
Please record below all temperatures within 15 days post-vaccination
CL Item
Fever (Axillary ≥ 37.5 °C; Rectal ≥ 38 °C) (1)
Item
Route
text
Route
Code List
Route
CL Item
Axillary (A)
CL Item
Rectal (R)
Item Group
Temperature Log
Item
Episode Number
text
Episode Number
Code List
Episode Number
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
CL Item
Day 8 (9)
CL Item
Day 9 (10)
CL Item
Day 10 (11)
CL Item
Day 11 (12)
CL Item
Day 12 (13)
CL Item
Day 13 (14)
CL Item
Day 14 (15)
Temperature
Item
Temperature
float
Item
not taken
text
not taken
Code List
not taken
CL Item
confirm (1)
If fever, Causality
Item
If fever, Causality
boolean
Medical advice
Item
Medical advice
boolean
Item Group
Fever Screen
Item
Day
text
Day
Code List
Day
CL Item
Day 15 (1)
CL Item
Day 16 (2)
CL Item
Day 17 (3)
CL Item
Day 18 (4)
CL Item
Day 19 (5)
CL Item
Day 20 (6)
CL Item
Day 21 (7)
CL Item
Day 22  (8)
CL Item
Day 23 (9)
CL Item
Day 24 (10)
CL Item
Day 25 (11)
CL Item
Day 26 (12)
CL Item
Day 27 (13)
CL Item
Day 28 (14)
CL Item
Day 29 (15)
CL Item
Day 30 (16)
CL Item
Day 31 (17)
CL Item
Day 32 (18)
CL Item
Day 33 (19)
CL Item
Day 34 (20)
CL Item
Day 35 (21)
CL Item
Day 36 (22)
CL Item
Day 37 (23)
CL Item
Day 38 (24)
CL Item
Day 39 (25)
CL Item
Day 40 (26)
CL Item
Day 41 (27)
CL Item
Day 42 (28)
Item
Fever
text
Fever
Code List
Fever
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
If Yes, record Temperature
Item
If Yes, record Temperature
float
Causality
Item
Causality
boolean
Medical Advice
Item
Medical Advice
boolean
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Visit
text
Visit
Code List
Visit
CL Item
Visit 2 (1)
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