Administration of vaccines not indicated by study protocol during clinical trial period | except for tetanus vaccine
Item
A: Administration of a vaccine (except tetanus toxoid) not foreseen by the study protocol during the period starting from 30 days before Dose 1 and ending 30 days after Dose 3.
boolean
C0042210 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
C1705847 (UMLS CUI [2,1])
C0039620 (UMLS CUI [2,2])
Investigational drug or investigational vaccine during clinical trial period | except for study vaccine
Item
B: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0042210 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C3854006 (UMLS CUI [3,2])
Immunoglobulins | blood products during clinical trial period
Item
C: Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0456388 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
Chronic immunosuppressive agents or biological response modifiers during clinical trial period | except for inhaled steroids | except for topical steroids
Item
D: Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period (for corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2064827 (UMLS CUI [4,2])