ELIMINATION CRITERIA
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.
text
Concomitant Medication
boolean
For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
boolean
mmunoglobulins
boolean
Concomitant Vaccination
boolean
INFORMED CONSENT
Informed Consent
boolean
Informed Consent Date
date
Further use of biological samples
text
DEMOGRAPHICS
Center number
integer
Date of Birth
date
Gender
text
Ethnicity
text
Race
text
Specify Other
text
Height
integer
Weight
float
ELIGIBILITY CHECK
If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria.
boolean
Eligibility Check Reminder
text
INCLUSION CRITERIA
Tick "No" corresponding to any of the inclusion criteria the subject failed.
boolean
Tick "No" corresponding to any of the inclusion criteria the subject failed.
boolean
Tick "No" corresponding to any of the inclusion criteria the subject failed.
boolean
Tick "No" corresponding to any of the inclusion criteria the subject failed.
boolean
Tick "No" corresponding to any of the inclusion criteria the subject failed.
boolean
EXCLUSION CRITERIA
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
boolean
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
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
boolean
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
Tick "Yes" corresponding to any of the exclusion criteria that disqualified the subject from entry.
boolean
TREATMENT ALLOCATION
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Status
text
DIAGNOSIS
text
Please report medication(s) as specified in the protocol and fill in the Medication section.
text
HISTORY OF INFLUENZA VACCINATION
LABORATORY TESTS
HCG URINE PREGNANCY TEST
VACCINE ADMINISTRATION
Date
date
Pre-Vaccination temperature
float
Route
text
Vaccine
text
According Protocol Non-dominant arm
text
According Protocol Deltoid
text
According Protocol I.M.
text
Comment
text
VACCINE NON-ADMINISTRATION
Please tick the major reason for non administration.
text
Please complete and submit SAE report
integer
AE No.
integer
e.g.: consent withdrawal, Protocol violation, …
text
Who made decision
text
IMMEDIATE POST-VACCINATION OBSERVATION
text
SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS
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.
text
Local Symptoms - Redness
Day
text
Redness
boolean
Redness Size
integer
Ongoing after Day 3?
boolean
Date
date
Medically attended visit
boolean
Medical Involvement
text
Local Symptoms - Swelling
Day
integer
Swelling
boolean
If Yes, record the size
integer
Ongoing after day 3?
boolean
If Yes, record date of last day of symptoms
date
Medically attended visit
boolean
If Yes, record the visit type
text
Local Symptoms - Induration
Day
text
Induration
boolean
Induration Size
integer
Ongoing after day 3?
boolean
Date
date
Medically attended visit
boolean
Medical Involvement
text
Local Symptoms - Ecchymosis
Day
integer
Ecchymosis
boolean
Ecchymosis Size
integer
Ongoing after Day 3?
boolean
Date
date
Medically attended visit
boolean
Medical Involvement
text
Local Symptoms - Pain
Day
text
Pain
boolean
Pain Intensity
integer
Ongoing after day 3?
boolean
Date
date
Medically attended visit
boolean
Medical Involvement
text
SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS
General Symptoms - Temperature
Day
text
Temperature
boolean
t°
float
Route
text
Temperature not taken
boolean
Ongoing after day 3?
boolean
Date
date
Causality
boolean
Medically attended visit
boolean
Medical Involvement
text
General Symptoms - Fatigue
Day
integer
Fatigue
boolean
Fatigue Intensity
text
Ongoing after day 3?
boolean
Date
boolean
Causality
boolean
Medically attended visit
boolean
Medical Involvement
text
General Symptoms - Headache
Day
integer
Headache
boolean
Headache Intensity
integer
Ongoing after day 3?
boolean
Date
date
Causality
boolean
Medically attended visit
boolean
Medical Involvement
text
General Symptoms - Myalgia
Day
text
Myalgia
boolean
Myalgia Intensity
text
Ongoing after day 3?
boolean
Date
date
Causality
boolean
Medically attended visit
boolean
Medical Involvement
text
General Symptoms - Shivering
Day
integer
Shivering
boolean
Shivering Intensity
integer
Ongoing after day 3?
boolean
Date
date
Causality
boolean
Medically attended visit
boolean
Medical Involvement
text
General Symptoms - Arthralgia
Day
text
Arthralgia
boolean
Arthralgia Intensity
text
Ongoing after day 3?
boolean
Date
date
Causality
boolean
Medically attended visit
boolean
Medical Involvement
text
General Symptoms - Sweating increase
Day
text
Sweating increase
boolean
Sweating increase Intensity
integer
Ongoing after day 3?
boolean
Date
date
Causality
boolean
Medically attended visit
boolean
Medical Involvement
text
UNSOLICITED ADVERSE EVENTS