ID

36821

Description

Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This document is to be completed at Visit 2.

Link

https://clinicaltrials.gov/ct2/show/NCT00323622

Keywords

Versions (4)
  1. 12/11/18 12/11/18 -
  2. 6/6/19 6/6/19 -
  3. 6/12/19 6/12/19 -
  4. 9/27/21 9/27/21 -
Copyright Holder

GSK group of companies

Uploaded on

June 12, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039

English

Visit 2: Laboratory Tests

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Blood Sample for Antibodies to CS
Description

Blood Sample for Antibodies to CS

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C3833453
UMLS CUI-3
C0525913
Has a blood sample been taken for antibodies to CS?
Description

For Cohorts 1 and 2 from Malaria-026

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C3833453
UMLS CUI [1,3]
C0525913
Date CS antibody sample taken
Description

if applicable; please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2,1]
C3833453
UMLS CUI [2,2]
C0525913
Blood Sample for Antibodies to HBs
Description

Blood Sample for Antibodies to HBs

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0948254
Has a blood sample been taken for antibodies to HBs?
Description

For Cohort 2 only from Malaria-026

Data type

text

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0948254
Date anti-HBs sample taken
Description

if applicable; please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0948254
Blood Sample for Hematocrit
Description

Blood Sample for Hematocrit

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0518014
Has a blood sample been taken for hematocrit?
Description

blood sample taken for hematocrit

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0518014
Date hematocrit sample taken
Description

if applicable, please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0518014
Has PCV (Packed cell volume) / Hematocrit test been done?
Description

Hematocrit test done

Data type

boolean

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C0884358
PCV (Packed cell volume) / Hematocrit Results
Description

if test was done

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0518014
%
Out of range values
Description

if applicable; please enter ONE code

Data type

integer

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C0600091
specify out of range values
Description

specification of out of range values

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0438215
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Similar models

Visit 2: Laboratory Tests

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Blood Sample for Antibodies to CS
C0005834 (UMLS CUI-1)
C3833453 (UMLS CUI-2)
C0525913 (UMLS CUI-3)
blood sample taken for antibodies to CS
Item
Has a blood sample been taken for antibodies to CS?
boolean
C1277698 (UMLS CUI [1,1])
C3833453 (UMLS CUI [1,2])
C0525913 (UMLS CUI [1,3])
Date CS antibody sample taken
Item
Date CS antibody sample taken
date
C1302413 (UMLS CUI [1])
C3833453 (UMLS CUI [2,1])
C0525913 (UMLS CUI [2,2])
Item Group
Blood Sample for Antibodies to HBs
C0005834 (UMLS CUI-1)
C0948254 (UMLS CUI-2)
Item
Has a blood sample been taken for antibodies to HBs?
text
C1277698 (UMLS CUI [1,1])
C0948254 (UMLS CUI [1,2])
Has a blood sample been taken for antibodies to HBs?
Code List
Has a blood sample been taken for antibodies to HBs?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (for Cohort 1) (3)
Date anti-HBs sample taken
Item
Date anti-HBs sample taken
date
C1302413 (UMLS CUI [1,1])
C0948254 (UMLS CUI [1,2])
Item Group
Blood Sample for Hematocrit
C0005834 (UMLS CUI-1)
C0518014 (UMLS CUI-2)
blood sample taken for hematocrit
Item
Has a blood sample been taken for hematocrit?
boolean
C1277698 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
Date hematocrit sample taken
Item
Date hematocrit sample taken
date
C1302413 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
Hematocrit test done
Item
Has PCV (Packed cell volume) / Hematocrit test been done?
boolean
C0518014 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Hematocrit
Item
PCV (Packed cell volume) / Hematocrit Results
float
C0518014 (UMLS CUI [1])
Item
Out of range values
integer
C0438215 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Out of range values
Code List
Out of range values
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)
specification of out of range values
Item
specify out of range values
text
C2348235 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
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