ID

33009

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 (2)
  1. 11/23/18 11/23/18 -
  2. 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 1: Temperature Form

1 forms  
Post-Dose Temperature
Description

Post-Dose 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

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Similar models

Visit 1: Temperature Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Post-Dose 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
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