ID
35601
Description
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
Keywords
Versions (1)
- 3/11/19 3/11/19 -
Copyright Holder
GSK group of companies
Uploaded on
March 11, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631
Diary Cards
- StudyEvent: ODM
Description
LOCAL SYMPTOMS (at injection site)
Description
Local Symptoms - Redness
Description
Day 0 = date of vaccination
Data type
text
Description
Redness Size
Data type
integer
Measurement units
- mm
Description
Ongoing after Day 3?
Data type
boolean
Description
Date
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
Local Symptoms - Swelling
Description
Day
Data type
text
Description
Redness Size
Data type
integer
Measurement units
- mm
Description
Ongoing after Day 3?
Data type
boolean
Description
Date
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
Local Symptoms - Induration
Description
Day
Data type
text
Description
Induration Size
Data type
integer
Measurement units
- mm
Description
Ongoing after Day 3?
Data type
boolean
Description
Date
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
Local Symptoms - Ecchymosis
Description
Day
Data type
text
Description
Ecchymosis Size
Data type
integer
Description
Ongoing after Day 3?
Data type
boolean
Description
Date of last Day of Symptoms
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
Local Symptoms - Pain
Description
Day
Data type
text
Description
Pain Intensity
Data type
text
Description
Ongoing after Day 3?
Data type
boolean
Description
Date of last Day of Symptoms
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
OTHER LOCAL SYMPTOMS (from Day 0 to Day 20)
Description
Description
Data type
text
Description
Intensity
Data type
text
Description
Start date
Data type
date
Description
End date
Data type
date
Description
Ongoing
Data type
boolean
Description
Medically attended Visit?
Data type
boolean
Description
MEDICATION
Description
Please fill in below if any medication has been taken since the vaccination
Data type
text
Description
Reason
Data type
text
Description
Total Daily Dose
Data type
text
Description
Start date
Data type
date
Description
End date
Data type
date
Description
Ongoing?
Data type
boolean
Description
GENERAL SYMPTOMS
Description
General Symptoms - Temperature
Description
Day
Data type
text
Description
t°
Data type
float
Measurement units
- °C
Description
Route
Data type
text
Description
Ongoing after Day 3?
Data type
boolean
Description
Date of last Day of Symptoms
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
General Symptoms - Fatigue
Description
Day
Data type
integer
Description
Fatigue Intensity
Data type
integer
Description
Ongoing after Day 3?
Data type
boolean
Description
Date of last Day of Symptoms
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
General Symptoms - Headache
Description
Day
Data type
integer
Description
Headache Intensity
Data type
text
Description
Ongoing after Day 3?
Data type
boolean
Description
Date of last Day of Symptoms
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
General Symptoms - Myalgia
Description
Day
Data type
integer
Description
Myalgia Intensity
Data type
text
Description
Ongoing after Day 3?
Data type
boolean
Description
Date of last Day of Symptoms
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
General Symptoms - Shivering
Description
Day
Data type
integer
Description
Shivering Intensity
Data type
text
Description
Ongoing after Day 3?
Data type
boolean
Description
Date of last Day of Symptoms
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
General Symptoms - Arthralgia
Description
Day
Data type
integer
Description
Arthralgia Intensity
Data type
text
Description
Ongoing after Day 3?
Data type
boolean
Description
Date of last Day of Symptoms
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
General Symptoms - Sweating increase
Description
Day
Data type
text
Description
Sweating increase intensity
Data type
text
Description
Ongoing after Day 3?
Data type
boolean
Description
Date of last Day of Symptoms
Data type
date
Description
Medically attended Visit?
Data type
boolean
Description
OTHER GENERAL SYMPTOMS
Description
from Day 0 to Day 20
Data type
text
Description
Intensity
Data type
text
Description
Start date
Data type
date
Description
End date
Data type
date
Description
Ongoing
Data type
boolean
Description
Medically attended Visit?
Data type
boolean
Description
Reminder
Similar models
Diary Cards
- StudyEvent: ODM