ID

42473

Beschrijving

Study ID: 106464 Clinical Study ID: 106464 Study Title: A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS, S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00380393 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/study/NCT00380393. This Phase IIb randomized, double-blind, controlled study of the efficacy against episodes of clinical malaria due to Plasmodium falciparum infection of GlaxoSmithKline Biologicals’ candidate vaccine RTS, S/AS01E, administered IM according to a 0, 1, 2-month vaccination schedule in children aged 5 months to 17 months living in Tanzania and Kenya. This study includes the following 7 clinical study visits (3 different visit types) during a double-blind phase (Day -60 to Month 6 1/2) and a single-blind phase including an extension for a subset of patients (month 7 to month 14). Clinical visit 1: Baseline visit, screening, and randomisation (DAY -60 to 0) Clinical visit 2: Vaccination I (MONTH 0, DAY 0 | DOSE 1 | 0 - 60 DAYS AFTER VISIT 1) Clinical visit 3: Vaccination II (MONTH 1, DAY 30 | DOSE 2 | 21 - 35 DAYS AFTER VISIT 2) Clinical visit 4: Vaccination III (MONTH 2, DAY 60 | DOSE 3 | 21 - 35 DAYS AFTER VISIT 3) Clinical visit 5: Blood Sample, ACD (MONTH 3, DAY 90 | 21 - 42 DAYS AFTER VISIT 4) Clinical visit 6: Blood Sample, ACD (MONTH 6 1/2 | CROSS-SECTIONAL VISIT FOR ACD | FINAL STUDY VISIT FOR DOUBLE-BLIND PHASE) Clinical visit 7: Blood Sample, ACD (MONTH 14 | FINAL STUDY VISIT SINGLE-BLIND PHASE) Field-worker home visits: During the vaccination period, clinical visits are accompanied by daily field-worker visits for a one-week period subsequent to each vaccine administration at clinical visits 2, 3, and 4 (visit code 21-26 following clinical visit 2; visit code 27-32 following clinical visit 3; visit code 33-38 following clinical visit 4). After completion of the vaccination period, clinical visits are then accompanied by weekly field-worker home visits (visit code 39-40 following clinical visit 4/dose 3; visit code 41-55 following clinical visit 5; visit code 56-86 following clinical visit 6). These visits serve the additional purpose of Active Case Detection (ACD). Passive Case Detection (PCD) for clinical malaria disease is performed both during the course of the double-blind (day -60 to month 6 1/2) and the single-blind phase (month 7 to month 14). Eligibility Criteria should be checked at visit 1 (screening) and visit 2. The Eligibility Criteria form is to be filled in at the screening visit. A check at visit 2 does not require documentation in the individual CRF. Note that informed consent has to be obtained prior to any study procedure.

Link

https://clinicaltrials.gov/ct2/show/study/NCT00380393

Trefwoorden

Versies (1)
  1. 08-07-21 08-07-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

8 juli 2021

DOI

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Licentie

Creative Commons BY-NC 4.0
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Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393

Engels

Eligibility

1 Formulieren  
  1. StudyEvent: ODM
    1. Eligibility
Administrative Documentation
Beschrijving

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Date of visit
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Eligibility Check
Beschrijving

Eligibility Check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria? If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.
Beschrijving

Eligibility Check

Datatype

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria, tick the boxes corresponding to any of the inclusion criteria the subject failed.
Beschrijving

Inclusion Criteria, tick the boxes corresponding to any of the inclusion criteria the subject failed.

Alias
UMLS CUI-1
C1512693
A male or female child of between 5 months and 17 months of age at the time of first vaccination.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child..
Beschrijving

Informed consent parent | Informed consent legal guardian

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Beschrijving

Parent's willingness ability to protocol compliance judgment clinical investigator | Legal guardian's willingness ability to protocol compliance judgment clinical investigator

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0600109
UMLS CUI [1,3]
C0030551
UMLS CUI [1,4]
C0022423
UMLS CUI [1,5]
C0008961
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0085732
UMLS CUI [2,3]
C0030551
UMLS CUI [2,4]
C0022423
UMLS CUI [2,5]
C0008961
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0600109
UMLS CUI [3,3]
C0023226
UMLS CUI [3,4]
C0022423
UMLS CUI [3,5]
C0008961
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C0085732
UMLS CUI [4,3]
C0023226
UMLS CUI [4,4]
C0022423
UMLS CUI [4,5]
C0008961
Exclusion Criteria, tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
Beschrijving

Exclusion Criteria, tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Alias
UMLS CUI-1
C0680251
Acute disease at the time of enrolment (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.
Beschrijving

Acute disease | moderate disease | severe disease

Datatype

boolean

Alias
UMLS CUI [1]
C0001314
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205082
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 allergic reactions significant IgE-mediated events or anaphylaxis to previous immunizations. *History of any neurologic disorders or seizures. *Malnutrition at screening defined as weight for age Z-score less than -3 or other clinical signs of malnutrition.
Beschrijving

Serious acute or chronic illness (clinical examination or laboratory screening tests) | immunosuppressive or immunodeficient condition, based on medical history and physical examination | family history of congenital or hereditary immunodeficiency | splenectomy | major congenital defects |  hypersensitivity or anaphylaxis to previous immunization | nervous system disorder | seizures | malnutrition z-score | malnutrition sign or symptom

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1456356
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1456356
UMLS CUI [3,1]
C0001314
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0587081
UMLS CUI [4,1]
C0008679
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0587081
UMLS CUI [5,1]
C4048329
UMLS CUI [5,2]
C0262926
UMLS CUI [5,3]
C0031809
UMLS CUI [6,1]
C0021051
UMLS CUI [6,2]
C0262926
UMLS CUI [6,3]
C0031809
UMLS CUI [7,1]
C0241889
UMLS CUI [7,2]
C0853602
UMLS CUI [8,1]
C0241889
UMLS CUI [8,2]
C0439660
UMLS CUI [8,3]
C0021051
UMLS CUI [9]
C0037995
UMLS CUI [10,1]
C0000768
UMLS CUI [10,2]
C0205164
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0205156
UMLS CUI [11,3]
C0020971
UMLS CUI [12,1]
C0002792
UMLS CUI [12,2]
C0205156
UMLS CUI [12,3]
C0020971
UMLS CUI [13]
C0027765
UMLS CUI [14]
C0036572
UMLS CUI [15,1]
C0162429
UMLS CUI [15,2]
C0871421
UMLS CUI [16,1]
C0162429
UMLS CUI [16,2]
C3540840
Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
Beschrijving

Acceptable limit / normal range: Hemoglobin: ≥ 8.0 g/dL Total white cell count: ≥ 4.0 x 10^3 /µL and < 17 x 10^3 /µ􏰃L Platelets: ≥ 75 x 10^3 /µL ALT: ≤ 60 IU/L Creatinine: ≤ 60 􏰃mol/L

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0005821
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201976
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 or scheduled diphtheria, pertussis or measles vaccine.
Beschrijving

Vaccination or planned vaccination not indicated by study protocol within 30 days | Except for tetanus, diphtheria, pertussis, or measles vaccine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C3845590
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C1444655
UMLS CUI [2,4]
C2348563
UMLS CUI [2,5]
C3845590
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0039620
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0012551
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0031237
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0025010
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Beschrijving

Recent investigational new drugs | investigational new drugs planned during clinical trial period | recent investigational vaccines | investigational vaccines planned during clinical trial period

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C2347804
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C1517586
UMLS CUI [3,3]
C0332185
UMLS CUI [4,1]
C0042210
UMLS CUI [4,2]
C1517586
UMLS CUI [4,3]
C1301732
UMLS CUI [4,4]
C0347984
UMLS CUI [4,5]
C2347804
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.
Beschrijving

Immunoglobulins | blood transfusions | blood products | recent or planned during clinical trial period

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0005841
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0456388
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C0021027
UMLS CUI [4,2]
C1301732
UMLS CUI [4,3]
C0347984
UMLS CUI [4,4]
C2347804
UMLS CUI [5,1]
C0005841
UMLS CUI [5,2]
C1301732
UMLS CUI [5,3]
C0347984
UMLS CUI [5,4]
C2347804
UMLS CUI [6,1]
C0456388
UMLS CUI [6,2]
C1301732
UMLS CUI [6,3]
C0347984
UMLS CUI [6,4]
C2347804
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).
Beschrijving

Chronic, recent immunosuppressive agents or biological response modifiers | except for inhaled steroids | except for topical steroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0332185
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2065041
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2064827
Previous participation in any other malaria vaccine trial.
Beschrijving

Study subject participation status previous clinical trial vaccine malaria

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0042210
UMLS CUI [1,5]
C0024530
Simultaneous participation in any other clinical trial.
Beschrijving

Study subject participation status current

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521116
Same sex twin.
Beschrijving

Twin sibling same gender

Datatype

boolean

Alias
UMLS CUI [1,1]
C0041427
UMLS CUI [1,2]
C0079399
UMLS CUI [1,3]
C0445247
History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
Beschrijving

Hypersensitivity or anaphylaxis to previous immunizations

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0020971
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0020971
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Beschrijving

History of hypersensitivity with probable disease exacerbation by vaccine component

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0750492
UMLS CUI [1,4]
C0235874
UMLS CUI [1,5]
C0042210
UMLS CUI [1,6]
C1550600
Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Beschrijving

Other finding participation status risk patient outcome judgment clinical investigators

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0035647
UMLS CUI [1,5]
C1547647
UMLS CUI [1,6]
C0022423
UMLS CUI [1,7]
C0008961
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Similar models

Eligibility

1 Formulieren
  1. StudyEvent: ODM
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Eligibility Check
Item
Did the subject meet all the entry criteria? If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria, tick the boxes corresponding to any of the inclusion criteria the subject failed.
C1512693 (UMLS CUI-1)
Age
Item
A male or female child of between 5 months and 17 months of age at the time of first vaccination.
boolean
C0001779 (UMLS CUI [1])
Informed consent parent | Informed consent legal 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])
C0023226 (UMLS CUI [2,2])
Parent's willingness ability to protocol compliance judgment clinical investigator | Legal guardian's willingness ability to protocol compliance judgment clinical investigator
Item
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0030551 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C0008961 (UMLS CUI [1,5])
C0525058 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
C0030551 (UMLS CUI [2,3])
C0022423 (UMLS CUI [2,4])
C0008961 (UMLS CUI [2,5])
C0525058 (UMLS CUI [3,1])
C0600109 (UMLS CUI [3,2])
C0023226 (UMLS CUI [3,3])
C0022423 (UMLS CUI [3,4])
C0008961 (UMLS CUI [3,5])
C0525058 (UMLS CUI [4,1])
C0085732 (UMLS CUI [4,2])
C0023226 (UMLS CUI [4,3])
C0022423 (UMLS CUI [4,4])
C0008961 (UMLS CUI [4,5])
Item Group
Exclusion Criteria, tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
C0680251 (UMLS CUI-1)
Acute disease | moderate disease | severe disease
Item
Acute disease at the time of enrolment (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])
C0012634 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Serious acute or chronic illness (clinical examination or laboratory screening tests) | immunosuppressive or immunodeficient condition, based on medical history and physical examination | family history of congenital or hereditary immunodeficiency | splenectomy | major congenital defects |  hypersensitivity or anaphylaxis to previous immunization | nervous system disorder | seizures | malnutrition z-score | malnutrition sign or symptom
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 allergic reactions significant IgE-mediated events or anaphylaxis to previous immunizations. *History of any neurologic disorders or seizures. *Malnutrition at screening defined as weight for age Z-score less than -3 or other clinical signs of malnutrition.
boolean
C0001314 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1456356 (UMLS CUI [2,3])
C0001314 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0587081 (UMLS CUI [3,3])
C0008679 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0587081 (UMLS CUI [4,3])
C4048329 (UMLS CUI [5,1])
C0262926 (UMLS CUI [5,2])
C0031809 (UMLS CUI [5,3])
C0021051 (UMLS CUI [6,1])
C0262926 (UMLS CUI [6,2])
C0031809 (UMLS CUI [6,3])
C0241889 (UMLS CUI [7,1])
C0853602 (UMLS CUI [7,2])
C0241889 (UMLS CUI [8,1])
C0439660 (UMLS CUI [8,2])
C0021051 (UMLS CUI [8,3])
C0037995 (UMLS CUI [9])
C0000768 (UMLS CUI [10,1])
C0205164 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0205156 (UMLS CUI [11,2])
C0020971 (UMLS CUI [11,3])
C0002792 (UMLS CUI [12,1])
C0205156 (UMLS CUI [12,2])
C0020971 (UMLS CUI [12,3])
C0027765 (UMLS CUI [13])
C0036572 (UMLS CUI [14])
C0162429 (UMLS CUI [15,1])
C0871421 (UMLS CUI [15,2])
C0162429 (UMLS CUI [16,1])
C3540840 (UMLS CUI [16,2])
Haemoglobin | white blood cell count | blood platelets | ALT | serum creatinine measurement
Item
Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
boolean
C0518015 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Vaccination or planned vaccination not indicated by study protocol within 30 days | Except for tetanus, diphtheria, pertussis, or measles vaccine
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 or scheduled diphtheria, pertussis or measles vaccine.
boolean
C0042196 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C3845590 (UMLS CUI [1,4])
C0042196 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1444655 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
C3845590 (UMLS CUI [2,5])
C1705847 (UMLS CUI [3,1])
C0039620 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0012551 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0031237 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0025010 (UMLS CUI [6,2])
Recent investigational new drugs | investigational new drugs planned during clinical trial period | recent investigational vaccines | investigational vaccines planned during clinical trial 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 the study period.
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
C0042210 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0042210 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
C0347984 (UMLS CUI [4,4])
C2347804 (UMLS CUI [4,5])
Immunoglobulins | blood transfusions | blood products | recent or planned during clinical trial 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])
C0005841 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0456388 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0021027 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0347984 (UMLS CUI [4,3])
C2347804 (UMLS CUI [4,4])
C0005841 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C0347984 (UMLS CUI [5,3])
C2347804 (UMLS CUI [5,4])
C0456388 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
C0347984 (UMLS CUI [6,3])
C2347804 (UMLS CUI [6,4])
Chronic, recent immunosuppressive agents or biological response modifiers | except for inhaled steroids | except for topical steroids
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).
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2064827 (UMLS CUI [4,2])
Study subject participation status previous clinical trial vaccine malaria
Item
Previous participation in any other malaria vaccine trial.
boolean
C2348568 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
C0024530 (UMLS CUI [1,5])
Study subject participation status current
Item
Simultaneous participation in any other clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Twin sibling same gender
Item
Same sex twin.
boolean
C0041427 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
Hypersensitivity 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 hypersensitivity with probable disease exacerbation by vaccine component
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])
C0042210 (UMLS CUI [1,5])
C1550600 (UMLS CUI [1,6])
Other finding participation status risk patient outcome judgment clinical investigators
Item
Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
boolean
C0243095 (UMLS CUI [1,1])
C0205394 (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])
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