Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
CL Item
Telephone Contact (7)
Administration of any vaccine not applicable with study protocol
Item
Administration of any vaccine (other than the candidate vaccines) between Day 0 and Day 42
boolean
C2368628 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Chronic administration of immunosuppressants or other immune-modifying drugs
Item
Chronic administration of immunosuppressants or other immune-modifying drugs during the study period. (For glucocorticoids, this will mean prednisone, or equivalent, >= 10 mg/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])
C2065041 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C2064827 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Administration of immunoglobulins and/or any blood products
Item
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])
Use of investigational or non-registered product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the candidate vaccine during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Pregnancy
Item
Pregnancy.
boolean
C0032961 (UMLS CUI [1])
Anaphylaxis to vaccination
Item
Anaphylaxis in response to an earlier vaccine dose
boolean
C0002792 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Medical condition, risk for investigational product/ change of compliance
Item
Discovery of any health condition which, in the investigator’s opinion, places the subject at increased risk from receipt of further investigational product; or discovery of a change in the subject’s status which renders him/her unable to comply with protocol-mandated safety follow-up.
boolean
C0012634 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0443172 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
Occurrence of AE
Item
If the following AE occurs prior to or at the time of the Day 21 scheduled visit, the subject may be withdrawn at the discretion of the investigator or the subject may be vaccinated at a later date, however, within the time window specified in the protocol. The subject must be followed until resolution of the event as with any AE
boolean
C2745955 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Acute disease
Item
Acute disease at the time of vaccination. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection with or without low-grade fever.
boolean
C0001314 (UMLS CUI [1])
C0683607 (UMLS CUI [2,1])
C0011991 (UMLS CUI [2,2])
C0683607 (UMLS CUI [3,1])
C0041912 (UMLS CUI [3,2])