ID

42519

Description

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). The laboratory tests form should be completed at visits 2, 5, 6, and 7. All questions for visit 2 relate to blood samples taken at visit 1 (screening visit). Note that informed consent has to be obtained prior to any study procedure.

Lien

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

Mots-clés

Versions (1)
  1. 11/08/2021 11/08/2021 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

11 août 2021

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Laboratory Tests

1 Formulaires  
  1. StudyEvent: ODM
    1. Laboratory Tests
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Visit number
Description

Visit number

Type de données

integer

Alias
UMLS CUI [1]
C1549755
Date of visit
Description

Date of visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Biochemistry
Description

Biochemistry

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

(For visit 2 only: Has a blood sample for biochemistry been taken at screening visit 1?) If yes, please complete the items below.

Type de données

boolean

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

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.)

Type de données

date

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

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

Type de données

integer

Unités de mesure
  • IU/L
Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1274040
IU/L
ALT not done
Description

Please indicate if ALT has not been tested for.

Type de données

boolean

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

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

Type de données

integer

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0600091
Out of range values specify
Description

If [2] Preexisting/concomitant medical condition or [5] Other has been selected in prior item, please specify.

Type de données

text

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

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

Type de données

integer

Unités de mesure
  • µmol/L
Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C1274040
µmol/L
Creatinine not done
Description

Please indicate if creatinine has not been tested for.

Type de données

boolean

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

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

Type de données

integer

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0600091
Out of range values specify
Description

If [2] Preexisting/concomitant medical condition or [5] Other has been selected in prior item, please specify.

Type de données

text

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C1521902
Haematology
Description

Haematology

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

(For visit 2 only: Has a blood sample for haematology been taken at screening visit 1?) If yes, please complete the items below.

Type de données

boolean

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

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.)

Type de données

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0011008
Haemoglobin not done
Description

Please indicate if haemoglobin has not been tested for.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C1272696
Haemoglobin results
Description

Please fill in results if haemoglobin has been tested for.

Type de données

float

Unités de mesure
  • g/dL
Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C1274040
g/dL
Out of range values code
Description

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

Type de données

integer

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0600091
Out of range values specify
Description

If [2] Preexisting/concomitant medical condition or [5] Other has been selected in prior item, please specify.

Type de données

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 not done
Description

Please indicate if WBC has not been tested for.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1272696
WBC (White blood cells) total results
Description

Please fill in results if WBC has been tested for.

Type de données

float

Unités de mesure
  • 10^3/µL
Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1274040
10^3/µL
Out of range values code
Description

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

Type de données

integer

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0600091
Out of range values specify
Description

If [2] Preexisting/concomitant medical condition or [5] Other has been selected in prior item, please specify.

Type de données

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C1521902
Platelets not done
Description

Please indicate if creatinine has not been tested for.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C1272696
Platelets results
Description

Please fill in results if creatinine has been tested for.

Type de données

float

Unités de mesure
  • 10^3/µL
Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C1274040
10^3/µL
Out of range values code
Description

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

Type de données

integer

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0600091
Out of range values specify
Description

If [2] Preexisting/concomitant medical condition or [5] Other has been selected in prior item, please specify.

Type de données

text

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

Serology

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

(For visit 2 only: Has a blood sample for serology been taken at screening visit 1?) If yes, please complete the item below.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0036743
Date of blood sample
Description

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.)

Type de données

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0036743
UMLS CUI [1,3]
C0011008
CMI Sample
Description

CMI Sample

Alias
UMLS CUI-1
C0020966
Has a blood sample been taken for CS-specific T-cells (ICS assay)?
Description

(For visit 2 only: Has a blood sample for cellular immunity been taken at screening visit 1?) If yes, please complete the item below.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0020966
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0039194
UMLS CUI [2,3]
C0055782
Date of blood sample
Description

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.)

Type de données

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0020966
UMLS CUI [1,3]
C0011008
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Similar models

Laboratory Tests

1 Formulaires
  1. StudyEvent: ODM
    1. Laboratory Tests
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
clinical visit 2 (2)
CL Item
clinical visit 5 (5)
CL Item
clinical visit 6 (6)
CL Item
clinical visit 7 (7)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (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)
CL Item
Preexisting/concomitant medical condition, please specify in table above (2)
CL Item
Prior/Concomitant Medication (3)
CL Item
Child is well – not investigated further (4)
CL Item
Other (5)
ALT abnormal reason to specify
Item
Out of range values 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 in table above (2)
CL Item
Prior/Concomitant Medication (3)
CL Item
Child is well – not investigated further (4)
CL Item
Other (5)
Creatinine abnormal reason to specify
Item
Out of range values specify
text
C0201975 (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 not done
Item
Haemoglobin not done
boolean
C0518015 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Haemoglobin result
Item
Haemoglobin results
float
C0518015 (UMLS CUI [1,1])
C1274040 (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 in table above (2)
CL Item
Prior/Concomitant Medication (3)
CL Item
Child is well – not investigated further (4)
CL Item
Other (5)
Haemoglobin abnormal reason to specify
Item
Out of range values 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 not done
Item
WBC (White blood cells) total not done
boolean
C0023508 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
White blood cell count procedure result
Item
WBC (White blood cells) total results
float
C0023508 (UMLS CUI [1,1])
C1274040 (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 in table above (2)
CL Item
Prior/Concomitant Medication (3)
CL Item
Child is well – not investigated further (4)
CL Item
Other (5)
White blood cell count procedure abnormal reason to specify
Item
Out of range values specify
text
C0023508 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Blood platelets not done
Item
Platelets not done
boolean
C0005821 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Blood platelets result
Item
Platelets results
float
C0005821 (UMLS CUI [1,1])
C1274040 (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 in table above (2)
CL Item
Prior/Concomitant Medication (3)
CL Item
Child is well – not investigated further (4)
CL Item
Other (5)
Blood platelets abnormal reason to specify
Item
Out of range values 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
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])
Specimen collection date serology
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
CMI Sample
C0020966 (UMLS CUI-1)
Collection of blood specimen for cellular immunity | circumsporozoite protein t-lymphocyte
Item
Has a blood sample been taken for CS-specific T-cells (ICS assay)?
boolean
C0005834 (UMLS CUI [1,1])
C0020966 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0039194 (UMLS CUI [2,2])
C0055782 (UMLS CUI [2,3])
Specimen collection date cellular immunity
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0020966 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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