ID

42578

Beschreibung

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 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 ODM derived from https://clinicaltrials.gov/ct2/show/NCT00307021. A Phase II randomized, double-blind bridging study of the safety and immunogenicity of GlaxoSmithKline Plasmodium falciparum 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 vaccination schedule in children aged 18 months to 4 years living in Gabon. Clinical Visits: 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). Vaccine administration takes place during visits 2, 4, and 5 (Visit 2 = Dose 1; Visit 4 = Dose 2; Visit 5 = Dose 3). Field-worker Visits: During the double-blind phase, clinical visits are accompanied by daily field-worker visits subsequent to each vaccine administration visit. Additional field-worker visits also take place during months 4 to 13 of the single-blind phase. The full laboratory tests form should be completed at visits 2, 6, and 7, whilst a partial version should be completed at visits 3 and 5. All questions for visit 2 relate to blood samples taken at visit 1 (screening visit). For visit 3, only the sections for clinical chemistry and haematology need to be considered. For visit 5, only the sections for serology and CMI need to be considered. Please note that informed consent has to be obtained prior to any study procedure.

Link

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

Stichworte

Versionen (2)
  1. 24.08.21 24.08.21 -
  2. 04.09.21 04.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. September 2021

DOI

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Lizenz

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

Englisch

Laboratory Tests

1 Formulare  
  1. StudyEvent: ODM
    1. Laboratory Tests
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit number
Beschreibung

The full form should be completed for visits 2, 6, and 7. For visit 3 please only fill in the sections for clinical chemistry and haematology. For visit 5, only the sections for serology and CMI need to be considered.

Datentyp

integer

Alias
UMLS CUI [1]
C1549755
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Biochemistry
Beschreibung

Biochemistry

Alias
UMLS CUI-1
C0008000
Has a blood sample been taken for biochemistry?
Beschreibung

(For visit 2 only: Has a blood sample for biochemistry been taken at screening visit 1?) If yes, please complete the items below. This item group does not need to be filled in for visit 5.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
Date of blood sample
Beschreibung

Please complete only if date of collection of blood specimen is different from visit date. (For visit 2 only: Please complete only if date of collection of blood specimen is different from date of screening visit 1.)

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0011008
ALT results
Beschreibung

Please fill in results for ALT measurement or indicate if not done in the following item.

Datentyp

integer

Maßeinheiten
  • IU/L
Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1274040
IU/L
ALT not done
Beschreibung

Please indicate if ALT has not been tested for.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1272696
Out of range values code
Beschreibung

Please enter ONE code (e.g. 1 or 2). If [2] Preexisting/concomitant medical condition or [5] Other, please specify in the following item.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0600091
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
Beschreibung

Alanine aminotransferase measurement abnormal reason to specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C1521902
Creatinine results
Beschreibung

Please fill in results for creatinine measurement or indicate if not done in the following item.

Datentyp

integer

Maßeinheiten
  • µmol/L
Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C1274040
µmol/L
Creatinine not done
Beschreibung

Please indicate if creatinine has not been tested for.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C1272696
Out of range values code
Beschreibung

Please enter ONE code (e.g. 1 or 2). If [2] Preexisting/concomitant medical condition or [5] Other, please specify in the following item.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0600091
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
Beschreibung

Creatinine measurement abnormal reason to specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C1521902
Bilirubin results
Beschreibung

Please fill in results for bilirubin measurement or indicate if not done in the following item.

Datentyp

float

Maßeinheiten
  • µmol/L
Alias
UMLS CUI [1,1]
C0344395
UMLS CUI [1,2]
C1274040
µmol/L
Bilirubin not done
Beschreibung

Please indicate if bilirubin has not been tested for.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0344395
UMLS CUI [1,2]
C1272696
Out of range values code
Beschreibung

Please enter ONE code (e.g. 1 or 2). If [2] Preexisting/concomitant medical condition or [5] Other, please specify in the following item.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0344395
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0600091
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
Beschreibung

Bilirubin measurement abnormal reason to specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0344395
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C1521902
Haematology
Beschreibung

Haematology

Alias
UMLS CUI-1
C0018941
Has a blood sample been taken for haematology?
Beschreibung

(For visit 2 only: Has a blood sample for haematology been taken at screening visit 1?) If yes, please complete the items below. This item group does not need to be filled in for visit 5.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
Date of blood sample
Beschreibung

Please complete only if date of collection of blood specimen is different from visit date. (For visit 2 only: Please complete only if date of collection of blood specimen is different from date of screening visit 1.)

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0011008
Haemoglobin results
Beschreibung

Please fill in results for haemoglobin measurement or indicate if not done in the following item.

Datentyp

integer

Maßeinheiten
  • g/dL
Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C1274040
g/dL
Haemoglobin not done
Beschreibung

Please indicate if haemoglobin has not been tested for.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C1272696
Out of range values code
Beschreibung

Please enter ONE code (e.g. 1 or 2). If [2] Preexisting/concomitant medical condition or [5] Other, please specify in the following item.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0600091
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
Beschreibung

Haemoglobin measurement abnormal reason to specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C1521902
WBC (White blood cells) total results
Beschreibung

Please fill in results for WBC measurement or indicate if not done in the following item.

Datentyp

float

Maßeinheiten
  • 10^3/µL
Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1274040
10^3/µL
WBC (White blood cells) total not done
Beschreibung

Please indicate if WBC has not been tested for.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1272696
Out of range values code
Beschreibung

Please enter ONE code (e.g. 1 or 2). If [2] Preexisting/concomitant medical condition or [5] Other, please specify in the following item.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0600091
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
Beschreibung

White blood cell count procedure abnormal reason to specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C1521902
Platelets results
Beschreibung

Please fill in results for blood platelets measurement or indicate if not done in the following item.

Datentyp

integer

Maßeinheiten
  • 10^3/µL
Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C1274040
10^3/µL
Platelets not done
Beschreibung

Please indicate if blood platelets have not been tested for.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C1272696
Out of range values code
Beschreibung

Please enter ONE code (e.g. 1 or 2). If [2] Preexisting/concomitant medical condition or [5] Other, please specify in the following item.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0600091
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
Beschreibung

Blood platelets abnormal reason to specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C1521902
Serology
Beschreibung

Serology

Alias
UMLS CUI-1
C0036743
Has a blood sample been taken for serology (antibodies to HBs and antibodies to CS)?
Beschreibung

(For visit 2 only: Has a blood sample for serology been taken at screening visit 1?) If yes, please complete the item below. This item group does not need to be filled in for visit 3.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0036743
UMLS CUI [1,3]
C0201478
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0036743
UMLS CUI [2,3]
C3833453
UMLS CUI [2,4]
C0055782
Date of blood sample
Beschreibung

Please complete only if date of collection of blood specimen is different from visit date. (For visit 2 only: Please complete only if date of collection of blood specimen is different from date of screening visit 1.)

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0036743
UMLS CUI [1,3]
C0201478
UMLS CUI [1,4]
C0011008
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0036743
UMLS CUI [2,3]
C3833453
UMLS CUI [2,4]
C0055782
UMLS CUI [2,5]
C0011008
CMI | B-Cell Memory
Beschreibung

CMI | B-Cell Memory

Alias
UMLS CUI-1
C0020966
UMLS CUI-3
C0682638
Has a blood sample been taken for CMI / B-Cell memory testing?
Beschreibung

(For visit 2 only: Has a blood sample been taken for CMI / B-Cell Memory testing at Screening - Visit 1?) If yes, please complete the item below. This item group does not need to be filled in for visit 3.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0020966
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0682638
UMLS CUI [2,3]
C0032148
Date of blood sample
Beschreibung

Please complete only if date of collection of blood specimen is different from visit date. (For visit 2 only: Please complete only if date of collection of blood specimen is different from date of screening visit 1.)

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0020966
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0682638
UMLS CUI [2,3]
C0032148
UMLS CUI [2,4]
C0011008
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Ähnliche Modelle

Laboratory Tests

1 Formulare
  1. StudyEvent: ODM
    1. Laboratory Tests
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
visit 2 (2)
CL Item
visit 3 (3)
CL Item
visit 5 (5)
CL Item
visit 6 (6)
CL Item
visit 7 (7)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Biochemistry
C0008000 (UMLS CUI-1)
Collection of blood specimen for clinical chemistry
Item
Has a blood sample been taken for biochemistry?
boolean
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Specimen collection date clinical chemistry
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Alanine aminotransferase measurement result
Item
ALT results
integer
C0201836 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Alanine aminotransferase measurement not done
Item
ALT not done
boolean
C0201836 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item
Out of range values code
integer
C0201836 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Out of range values:
Code List
Out of range values code
CL Item
Laboratory error (1)
(Comment:en)
CL Item
Preexisting/concomitant medical condition, please specify (2)
(Comment:en)
CL Item
Prior/Concomitant medication (3)
(Comment:en)
CL Item
Child is well – not investigated further (4)
(Comment:en)
CL Item
Other, please specify (5)
(Comment:en)
Alanine aminotransferase measurement abnormal reason to specify
Item
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
text
C0201836 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Creatinine measurement result
Item
Creatinine results
integer
C0201975 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Creatinine measurement not done
Item
Creatinine not done
boolean
C0201975 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item
Out of range values code
integer
C0201975 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Out of range values:
Code List
Out of range values code
CL Item
Laboratory error (1)
CL Item
Preexisting/concomitant medical condition, please specify (2)
CL Item
Prior/Concomitant medication (3)
CL Item
Child is well – not investigated further (4)
CL Item
Other, please specify (5)
Creatinine measurement abnormal reason to specify
Item
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
text
C0201975 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Bilirubin measurement result
Item
Bilirubin results
float
C0344395 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Bilirubin measurement not done
Item
Bilirubin not done
boolean
C0344395 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item
Out of range values code
integer
C0344395 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Out of range values:
Code List
Out of range values code
CL Item
Laboratory error (1)
CL Item
Preexisting/concomitant medical condition, please specify (2)
CL Item
Prior/Concomitant medication (3)
CL Item
Child is well – not investigated further (4)
CL Item
Other, please specify (5)
Bilirubin measurement abnormal reason to specify
Item
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
text
C0344395 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item Group
Haematology
C0018941 (UMLS CUI-1)
Collection of blood specimen for haematology
Item
Has a blood sample been taken for haematology?
boolean
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Specimen collection date haematology
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Haemoglobin measurement result
Item
Haemoglobin results
integer
C0518015 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Haemoglobin measurement not done
Item
Haemoglobin not done
boolean
C0518015 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item
Out of range values code
integer
C0518015 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Out of range values:
Code List
Out of range values code
CL Item
Laboratory error (1)
CL Item
Preexisting/concomitant medical condition, please specify (2)
CL Item
Prior/Concomitant medication (3)
CL Item
Child is well – not investigated further (4)
CL Item
Other, please specify (5)
Haemoglobin measurement abnormal reason to specify
Item
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
text
C0518015 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
White blood cell count procedure result
Item
WBC (White blood cells) total results
float
C0023508 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
White blood cell count procedure not done
Item
WBC (White blood cells) total not done
boolean
C0023508 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item
Out of range values code
integer
C0023508 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Out of range values:
Code List
Out of range values code
CL Item
Laboratory error (1)
CL Item
Preexisting/concomitant medical condition, please specify (2)
CL Item
Prior/Concomitant medication (3)
CL Item
Child is well – not investigated further (4)
CL Item
Other, please specify (5)
White blood cell count procedure abnormal reason to specify
Item
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
text
C0023508 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Blood platelets result
Item
Platelets results
integer
C0005821 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Blood platelets not done
Item
Platelets not done
boolean
C0005821 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item
Out of range values code
integer
C0005821 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Out of range values:
Code List
Out of range values code
CL Item
Laboratory error (1)
CL Item
Preexisting/concomitant medical condition, please specify (2)
CL Item
Prior/Concomitant medication (3)
CL Item
Child is well – not investigated further (4)
CL Item
Other, please specify (5)
Blood platelets abnormal reason to specify
Item
If [2] Preexisting/concomitant medical condition or [5] Other, please specify
text
C0005821 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item Group
Serology
C0036743 (UMLS CUI-1)
Collection of blood specimen for serology Hepatitis B | circumsporozoite antibodies
Item
Has a blood sample been taken for serology (antibodies to HBs and antibodies to CS)?
boolean
C0005834 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
C0201478 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2,1])
C0036743 (UMLS CUI [2,2])
C3833453 (UMLS CUI [2,3])
C0055782 (UMLS CUI [2,4])
Specimen collection date serology Hepatitis B | circumsporozoite antibodies
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
C0201478 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0005834 (UMLS CUI [2,1])
C0036743 (UMLS CUI [2,2])
C3833453 (UMLS CUI [2,3])
C0055782 (UMLS CUI [2,4])
C0011008 (UMLS CUI [2,5])
Item Group
CMI | B-Cell Memory
C0020966 (UMLS CUI-1)
C0682638 (UMLS CUI-3)
Collection of blood specimen for cellular immunity | memory b-lymphocyte plasmodium
Item
Has a blood sample been taken for CMI / B-Cell memory testing?
boolean
C0005834 (UMLS CUI [1,1])
C0020966 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0682638 (UMLS CUI [2,2])
C0032148 (UMLS CUI [2,3])
Specimen collection date cellular immunity | memory b-lymphocyte plasmodium
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0020966 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2,1])
C0682638 (UMLS CUI [2,2])
C0032148 (UMLS CUI [2,3])
C0011008 (UMLS CUI [2,4])
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