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35601
Beschrijving
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza
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Versies (1)
- 11-03-19 11-03-19 -
Houder van rechten
GSK group of companies
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11 maart 2019
DOI
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Creative Commons BY-NC 3.0
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Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631
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Diary Cards
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject Number
Item
Subject Number
integer
occurrence of local symptoms
Item
Please fill in below and assess the occurrence of any of the following signs or symptoms
text
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Redness Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Redness Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Induration Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Ecchymosis Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Absent (1)
CL Item
Painful on touch (2)
CL Item
Painful when limb is moved (3)
CL Item
Pain that prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Description
Item
Description - please specify side(s) and site(s)
text
CL Item
Mild: An adverse event which is easily tolerated, causing minimal discomfort and not interfering with (1)
CL Item
everyday activities. (everyday activities.)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities. (In adults/ adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy). (3)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing
Item
Ongoing?
boolean
Medically attended Visit?
Item
Medically attended Visit?
boolean
Trade/Generic name
Item
Trade/Generic name
text
Reason
Item
Reason
text
Total Daily Dose
Item
Total Daily Dose
text
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing?
Item
Ongoing?
boolean
Day 0 = date of vaccination
Item
Day 0 = date of vaccination
date
Assessment of signs or symptoms
Item
Please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed hereafter:
text
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
t°
Item
t°
float
CL Item
Axilliary (preferred) (1)
CL Item
Oral (2)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Normal (1)
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Normal (1)
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Normal (1)
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Normal (1)
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Normal (1)
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Normal (1)
CL Item
Easily tolerated (2)
CL Item
Interferes with normal activity (3)
CL Item
That prevents normal activity (4)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
Medically attended Visit?
Item
Medically attended Visit?
boolean
Description
Item
Description - please specify side(s) and site(s)
text
CL Item
Mild: An adverse event which is easily tolerated, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities. (In adults or adolescents, such an adverse would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy). (3)
Start date
Item
Start date
date
End date
Item
End date
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Ongoing
Item
Ongoing?
boolean
Medically attended Visit?
Item
Medically attended Visit?
boolean
Diary Card date
Item
PLEASE DO NOT FORGET TO BRING BACK THE DIARY CARD ON
date
contact person
Item
IN CASE OF HOSPITALISATION, PLEASE INFORM
text