ID

33521

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

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

December 11, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate in Mozambican children (1 to 4 y.o) - 104297 (Malaria039)

English

Visit 2: Laboratory Tests - Serology

1 forms  
Administrative data
Description

Administrative data

Protocol Number
Description

Protocol Number

Data type

integer

Subject Number
Description

Subject Number

Data type

integer

Visit
Description

Visit

Data type

text

Blood Sample for Antibodies to CS
Description

Blood Sample for Antibodies to CS

Has a blood sample been taken for antibodies to CS?
Description

For Cohort 2 only from Malaria-026

Data type

boolean

Date sample taken
Description

Date sample taken

Data type

date

Blood Sample for Antibodies to HBs
Description

Blood Sample for Antibodies to HBs

Has a blood sample been taken for antibodies to HBs?
Description

For Cohort 2 only from Malaria-026

Data type

text

Date sample taken
Description

Date sample taken

Data type

date

Blood Sample for Hematocrit
Description

Blood Sample for Hematocrit

Has a blood sample been taken for hematocrit?
Description

Has a blood sample been taken for hematocrit?

Data type

boolean

Date sample taken
Description

Date sample taken

Data type

date

Test
Description

Test

PCV (Packed cell volume) / Hematocrit
Description

PCV (Packed cell volume) / Hematocrit

Data type

text

Results
Description

Results

Data type

float

Measurement units
  • %
%
Out of range values
Description

Out of range values

Data type

integer

If Other, please specify
Description

If Other, please specify

Data type

text

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Similar models

Visit 2: Laboratory Tests - Serology

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Protocol Number
Item
Protocol Number
integer
Subject Number
Item
Subject Number
integer
Item
Visit
text
Visit
Code List
Visit
CL Item
Visit 2, Study month 33 (33 months post dose 1 in Malaria-026, 12 months after visit 1) (1)
Item Group
Blood Sample for Antibodies to CS
Has a blood sample been taken for antibodies to CS?
Item
Has a blood sample been taken for antibodies to CS?
boolean
Date sample taken
Item
Date sample taken
date
Item Group
Blood Sample for Antibodies to HBs
Item
Has a blood sample been taken for antibodies to HBs?
text
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 sample taken
Item
Date sample taken
date
Item Group
Blood Sample for Hematocrit
Has a blood sample been taken for hematocrit?
Item
Has a blood sample been taken for hematocrit?
boolean
Date sample taken
Item
Date sample taken
date
Item Group
Test
Item
PCV (Packed cell volume) / Hematocrit
text
PCV (Packed cell volume) / Hematocrit
Code List
PCV (Packed cell volume) / Hematocrit
CL Item
Done (1)
CL Item
Not done (2)
Results
Item
Results
float
Item
Out of range values
integer
Out of range values
Code List
Out of range values
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)
If Other, please specify
Item
If Other, please specify
text
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