Eligibility

1 forms
  1. StudyEvent: ODM
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Centre number
Item
Centre number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Treatment number
Item
Treatment number
text
C1522541 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Check
C1516637 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Entry Criteria met
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. (N)
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
Age at first vaccination, Gender
Item
A male or female child between 18 months and 4 years of age (up to but not including 5th birthday) at the time of first vaccination.
boolean
C0001779 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
Informed consent from parent or guardian
Item
Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Investigator believes parent/guardian will comply with requirements of study
Item
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C0008961 (UMLS CUI [1,4])
C0525058 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
C0022423 (UMLS CUI [2,3])
C0008961 (UMLS CUI [2,4])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Acute moderate or severe disease at time of enrollment
Item
Acute disease at the time of enrollment (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 diarrhea or mild upper respiratory infection without fever, i.e. axillary temperature < 37,5°C.
boolean
C0001314 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C4041024 (UMLS CUI [1,3])
C0001314 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4041024 (UMLS CUI [2,3])
Serious acute or chronic illness determined by clinical or physical examination (history of immunosuppressive or immunodeficient condition, family history of congenital or hereditary immunodeficiency, history of splenectomy, major congenital birth defects, history on neurologic disorder or seizures, weight for age Z-score)
Item
Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests including, but not limited to: any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required); a family history of congenital or hereditary immunodeficiency; history of splenectomy; major congenital defects; history of any neurologic disorders or seizures; moderate malnutrition at screening defined as weight for age Z-score less than -2
boolean
C0205404 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C0205404 (UMLS CUI [2,1])
C0008679 (UMLS CUI [2,2])
C1456356 (UMLS CUI [2,3])
C0205404 (UMLS CUI [3,1])
C0001314 (UMLS CUI [3,2])
C0031809 (UMLS CUI [3,3])
C0205404 (UMLS CUI [4,1])
C0001314 (UMLS CUI [4,2])
C1456356 (UMLS CUI [4,3])
C0021051 (UMLS CUI [5,1])
C0262926 (UMLS CUI [5,2])
C4048329 (UMLS CUI [6,1])
C0262926 (UMLS CUI [6,2])
C0241889 (UMLS CUI [7,1])
C0853602 (UMLS CUI [7,2])
C0439660 (UMLS CUI [8,1])
C0021051 (UMLS CUI [8,2])
C0262926 (UMLS CUI [9,1])
C0027765 (UMLS CUI [9,2])
C0262926 (UMLS CUI [10,1])
C0036572 (UMLS CUI [10,2])
C0871421 (UMLS CUI [11,1])
C0517416 (UMLS CUI [11,2])
C0205164 (UMLS CUI [12,1])
C0220810 (UMLS CUI [12,2])
C0262926 (UMLS CUI [13,1])
C0037995 (UMLS CUI [13,2])
Laboratory screening tests out of range, specifically hemoglobin, total white cell count, platelets, ALT and creatinine.
Item
Laboratory screening tests out of range, specifically hemoglobin, total white cell count, platelets, ALT and creatinine.
boolean
C0518015 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Planned administration of other vaccine within 30 days of the first dose of vaccine, except tetanus toxoid
Item
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid.
boolean
C2368628 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0332300 (UMLS CUI [1,4])
C0199807 (UMLS CUI [1,5])
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during study period
Item
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during study period
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1517586 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C1301732 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C2347804 (UMLS CUI [3,4])
C1301732 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
C0042210 (UMLS CUI [4,3])
C0347984 (UMLS CUI [4,4])
C2347804 (UMLS CUI [4,5])
Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Item
Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0371802 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3,1])
C0456388 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0021027 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0347984 (UMLS CUI [4,3])
C2347804 (UMLS CUI [4,4])
C0371802 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C0347984 (UMLS CUI [5,3])
C2347804 (UMLS CUI [5,4])
C0205394 (UMLS CUI [6,1])
C0456388 (UMLS CUI [6,2])
C1301732 (UMLS CUI [6,3])
C0347984 (UMLS CUI [6,4])
C2347804 (UMLS CUI [6,5])
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
Item
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, >= 0,5 mg/kg/day. Inhaled and topical steroids are allowed).
integer
C0205191 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0205191 (UMLS CUI [2,1])
C0005525 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2064827 (UMLS CUI [4,2])
Previous participation in any other malaria vaccine trial
Item
Previous participation in any other malaria vaccine trial
boolean
C2348568 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1519888 (UMLS CUI [1,4])
C0024530 (UMLS CUI [1,5])
Simultaneous participation in any other clinical trial
Item
Simultaneous participation in any other clinical trial
boolean
C2348568 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Same sex twin
Item
Same sex twin
boolean
C0041427 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
Item
History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
boolean
C0020517 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0020971 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0020971 (UMLS CUI [2,3])
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0750492 (UMLS CUI [1,3])
C0235874 (UMLS CUI [1,4])
C1705248 (UMLS CUI [1,5])
C0042210 (UMLS CUI [1,6])
Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial
Item
Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial
boolean
C0205394 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0035647 (UMLS CUI [1,4])
C1547647 (UMLS CUI [1,5])
C0022423 (UMLS CUI [1,6])
C0008961 (UMLS CUI [1,7])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial