ID

41645

Descrição

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form (Eligibility) is to be filled out at Visit 1 (Day -28 to day 0).

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Palavras-chave

Versões (2)
  1. 01/12/2020 01/12/2020 -
  2. 05/12/2020 05/12/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

1 de dezembro de 2020

DOI

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Licença

Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

Inglês

Eligibility

1 Formulários  
  1. StudyEvent: ODM
    1. Eligibility
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Centre number
Descrição

Centre number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Subject number
Descrição

Subject number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Treatment number
Descrição

Treatment number

Tipo de dados

text

Alias
UMLS CUI [1]
C1522541
Date of visit
Descrição

Date of visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Eligibility Check
Descrição

Eligibility Check

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Descrição

Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1516637
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.
Descrição

Age at first vaccination, Gender

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0042196
UMLS CUI [2]
C0079399
Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
Descrição

Informed consent from parent or guardian

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
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.
Descrição

Investigator believes parent/guardian will comply with requirements of study

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0030551
UMLS CUI [1,3]
C0022423
UMLS CUI [1,4]
C0008961
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1274041
UMLS CUI [2,3]
C0022423
UMLS CUI [2,4]
C0008961
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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.
Descrição

Acute moderate or severe disease at time of enrollment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C4041024
UMLS CUI [2,1]
C0001314
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C4041024
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
Descrição

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)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205404
UMLS CUI [1,2]
C0008679
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C0205404
UMLS CUI [2,2]
C0008679
UMLS CUI [2,3]
C1456356
UMLS CUI [3,1]
C0205404
UMLS CUI [3,2]
C0001314
UMLS CUI [3,3]
C0031809
UMLS CUI [4,1]
C0205404
UMLS CUI [4,2]
C0001314
UMLS CUI [4,3]
C1456356
UMLS CUI [5,1]
C0021051
UMLS CUI [5,2]
C0262926
UMLS CUI [6,1]
C4048329
UMLS CUI [6,2]
C0262926
UMLS CUI [7,1]
C0241889
UMLS CUI [7,2]
C0853602
UMLS CUI [8,1]
C0439660
UMLS CUI [8,2]
C0021051
UMLS CUI [9,1]
C0262926
UMLS CUI [9,2]
C0027765
UMLS CUI [10,1]
C0262926
UMLS CUI [10,2]
C0036572
UMLS CUI [11,1]
C0871421
UMLS CUI [11,2]
C0517416
UMLS CUI [12,1]
C0205164
UMLS CUI [12,2]
C0220810
UMLS CUI [13,1]
C0262926
UMLS CUI [13,2]
C0037995
Laboratory screening tests out of range, specifically hemoglobin, total white cell count, platelets, ALT and creatinine.
Descrição

Acceptable limit/normal range: Hemoglobin >= 8.0 g/dL Total white cell count: >= 4.0x10^3/µL and <17x10^3/µL Platelets: >= 100x10^3/µL ALT: <= 60 µmol/L Creatinine: <= 60 µmol/L

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
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.
Descrição

Planned administration of other vaccine within 30 days of the first dose of vaccine, except tetanus toxoid

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1301732
UMLS CUI [1,4]
C0332300
UMLS CUI [1,5]
C0199807
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
Descrição

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

Tipo de dados

boolean

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

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.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0371802
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0205394
UMLS CUI [3,2]
C0456388
UMLS CUI [3,3]
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]
C0371802
UMLS CUI [5,2]
C1301732
UMLS CUI [5,3]
C0347984
UMLS CUI [5,4]
C2347804
UMLS CUI [6,1]
C0205394
UMLS CUI [6,2]
C0456388
UMLS CUI [6,3]
C1301732
UMLS CUI [6,4]
C0347984
UMLS CUI [6,5]
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).
Descrição

Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0205191
UMLS CUI [1,2]
C0021081
UMLS CUI [2,1]
C0205191
UMLS CUI [2,2]
C0005525
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
Descrição

Previous participation in any other malaria vaccine trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C1519888
UMLS CUI [1,5]
C0024530
Simultaneous participation in any other clinical trial
Descrição

Simultaneous participation in any other clinical trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521115
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0008976
Same sex twin
Descrição

Same sex twin

Tipo de dados

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.
Descrição

History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.

Tipo de dados

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
Descrição

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine

Tipo de dados

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]
C1705248
UMLS CUI [1,6]
C0042210
Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial
Descrição

Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0348080
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 Formulários
  1. StudyEvent: ODM
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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