Use of investigational new drug
Item
[ A ] Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Immunosuppressants | Immune-modifying drugs
Item
[ B ] Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, x 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Meningococcal vaccine
Item
[ C ] Administration of a meningococcal vaccine not planned by the protocol during the whole study period.
boolean
C0700144 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Other vaccine
Item
[ D ] Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
boolean
C2368628 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Immunoglobulins | Blood products
Item
[ E ] Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1])
C0371802 (UMLS CUI [2])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Serious adverse Event
Item
Has the subject had any serious adverse event since the end of the primary phase and before the start of this booster vaccination ?
boolean
C1519255 (UMLS CUI [1])
Number of SAE
Item
Specify number of SAE’s : Check SAE form(s) have been submitted to GSK Biologicals.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])