ID
35591
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 0" Vaccination
- 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
INFORMED CONSENT
Description
Informed Consent
Data type
boolean
Description
Informed Consent Date
Data type
date
Description
Further use of biological samples
Data type
text
Description
DEMOGRAPHICS
Description
Center number
Data type
integer
Description
Date of Birth
Data type
date
Description
Gender
Data type
text
Description
Ethnicity
Data type
text
Description
Race
Data type
text
Description
Specify Other
Data type
text
Description
Height
Data type
integer
Measurement units
- cm
Description
Weight
Data type
float
Measurement units
- kg
Description
ELIGIBILITY CHECK
Description
If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria.
Data type
boolean
Description
Eligibility Check Reminder
Data type
text
Description
INCLUSION CRITERIA
Description
Tick "No" corresponding to any of the inclusion criteria the subject failed.
Data type
boolean
Description
Tick "No" corresponding to any of the inclusion criteria the subject failed.
Data type
boolean
Description
Tick "No" corresponding to any of the inclusion criteria the subject failed.
Data type
boolean
Description
Tick "No" corresponding to any of the inclusion criteria the subject failed.
Data type
boolean
Description
Tick "No" corresponding to any of the inclusion criteria the subject failed.
Data type
boolean
Description
EXCLUSION CRITERIA
Description
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
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
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without lowgrade febrile illness, i.e. Axillary temperature <37.5°C
Data type
boolean
Description
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Description
TREATMENT ALLOCATION
Description
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Status
Data type
text
Description
DIAGNOSIS
Data type
text
Description
Please report medication(s) as specified in the protocol and fill in the Medication section.
Data type
text
Description
HISTORY OF INFLUENZA VACCINATION
Description
LABORATORY TESTS
Description
HCG URINE PREGNANCY TEST
Description
VACCINE ADMINISTRATION
Description
Date
Data type
date
Description
Pre-Vaccination temperature
Data type
float
Measurement units
- °C
Description
Route
Data type
text
Description
Vaccine
Data type
text
Description
According Protocol Non-dominant arm
Data type
text
Description
According Protocol Deltoid
Data type
text
Description
According Protocol I.M.
Data type
text
Description
Comment
Data type
text
Description
VACCINE NON-ADMINISTRATION
Description
Please tick the major reason for non administration.
Data type
text
Description
Please complete and submit SAE report
Data type
integer
Description
AE No.
Data type
integer
Description
e.g.: consent withdrawal, Protocol violation, …
Data type
text
Description
Who made decision
Data type
text
Description
IMMEDIATE POST-VACCINATION OBSERVATION
Data type
text
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 0" Vaccination
- StudyEvent: ODM