ID
35594
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 1 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
Visit "Day 21"
- StudyEvent: ODM
Description
ELIMINATION CRITERIA
Description
If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject’s evaluability in the according-to-protocol (ATP) analysis.
Data type
text
Description
Concomitant Medication
Data type
boolean
Description
For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
Data type
boolean
Description
mmunoglobulins
Data type
boolean
Description
Concomitant Vaccination
Data type
boolean
Description
CHECK FOR STUDY CONTINUATION
Description
check for study continuation
Data type
boolean
Description
Reason for withdrawal
Data type
text
Description
SAE No.
Data type
integer
Description
AE No.
Data type
integer
Description
e.g.: consent withdrawal, Protocol violation, …
Data type
text
Description
Please tick who made the decision
Data type
text
Description
LABORATORY TESTS
Description
SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS
Description
If any of these adverse events meets the protocol definition of serious, please complete and submit a Serious Adverse Event report to GSK Biologicals Study Contact for SAE reporting within 24 hours.
Data type
text
Description
Local Symptoms - Redness
Description
Day
Data type
text
Description
Redness
Data type
boolean
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
Medical Involvement
Data type
text
Description
Local Symptoms - Swelling
Description
Day
Data type
integer
Description
Swelling
Data type
boolean
Description
If Yes, record the size
Data type
integer
Measurement units
- mm
Description
Ongoing after day 3?
Data type
boolean
Description
If Yes, record date of last day of symptoms
Data type
date
Description
Medically attended visit
Data type
boolean
Description
If Yes, record the visit type
Data type
text
Description
Local Symptoms - Induration
Description
Day
Data type
text
Description
Induration
Data type
boolean
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
Medical Involvement
Data type
text
Description
Local Symptoms - Ecchymosis
Description
Day
Data type
integer
Description
Ecchymosis
Data type
boolean
Description
Ecchymosis 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
Medical Involvement
Data type
text
Description
Local Symptoms - Pain
Description
Day
Data type
text
Description
Pain
Data type
boolean
Description
Pain Intensity
Data type
integer
Description
Ongoing after day 3?
Data type
boolean
Description
Date
Data type
date
Description
Medically attended visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS
Description
General Symptoms - Temperature
Description
Day
Data type
text
Description
Temperature
Data type
boolean
Description
t°
Data type
float
Measurement units
- °C
Description
Route
Data type
text
Description
Temperature not taken
Data type
boolean
Description
Ongoing after day 3?
Data type
boolean
Description
Date
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
General Symptoms - Fatigue
Description
Day
Data type
integer
Description
Fatigue
Data type
boolean
Description
Fatigue Intensity
Data type
text
Description
Ongoing after day 3?
Data type
boolean
Description
Date
Data type
boolean
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
General Symptoms - Headache
Description
Day
Data type
integer
Description
Headache
Data type
boolean
Description
Headache Intensity
Data type
integer
Description
Ongoing after day 3?
Data type
boolean
Description
Date
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
General Symptoms - Myalgia
Description
Day
Data type
text
Description
Myalgia
Data type
boolean
Description
Myalgia Intensity
Data type
text
Description
Ongoing after day 3?
Data type
boolean
Description
Date
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
General Symptoms - Shivering
Description
Day
Data type
integer
Description
Shivering
Data type
boolean
Description
Shivering Intensity
Data type
integer
Description
Ongoing after day 3?
Data type
boolean
Description
Date
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
General Symptoms - Arthralgia
Description
Day
Data type
text
Description
Arthralgia
Data type
boolean
Description
Arthralgia Intensity
Data type
text
Description
Ongoing after day 3?
Data type
boolean
Description
Date
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
General Symptoms - Sweating increase
Description
Day
Data type
text
Description
Sweating increase
Data type
boolean
Description
Sweating increase Intensity
Data type
integer
Description
Ongoing after day 3?
Data type
boolean
Description
Date
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
UNSOLICITED ADVERSE EVENTS
Similar models
Visit "Day 21"
- StudyEvent: ODM