ID

33521

Beschrijving

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

Trefwoorden

  1. 11-12-18 11-12-18 -
  2. 06-06-19 06-06-19 -
  3. 12-06-19 12-06-19 -
  4. 27-09-21 27-09-21 -
Houder van rechten

GSK group of companies

Geüploaded op

11 december 2018

DOI

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Licentie

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)

Visit 2: Laboratory Tests - Serology

Administrative data
Beschrijving

Administrative data

Protocol Number
Beschrijving

Protocol Number

Datatype

integer

Subject Number
Beschrijving

Subject Number

Datatype

integer

Visit
Beschrijving

Visit

Datatype

text

Blood Sample for Antibodies to CS
Beschrijving

Blood Sample for Antibodies to CS

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

For Cohort 2 only from Malaria-026

Datatype

boolean

Date sample taken
Beschrijving

Date sample taken

Datatype

date

Blood Sample for Antibodies to HBs
Beschrijving

Blood Sample for Antibodies to HBs

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

For Cohort 2 only from Malaria-026

Datatype

text

Date sample taken
Beschrijving

Date sample taken

Datatype

date

Blood Sample for Hematocrit
Beschrijving

Blood Sample for Hematocrit

Has a blood sample been taken for hematocrit?
Beschrijving

Has a blood sample been taken for hematocrit?

Datatype

boolean

Date sample taken
Beschrijving

Date sample taken

Datatype

date

Test
Beschrijving

Test

PCV (Packed cell volume) / Hematocrit
Beschrijving

PCV (Packed cell volume) / Hematocrit

Datatype

text

Results
Beschrijving

Results

Datatype

float

Maateenheden
  • %
%
Out of range values
Beschrijving

Out of range values

Datatype

integer

If Other, please specify
Beschrijving

If Other, please specify

Datatype

text

Similar models

Visit 2: Laboratory Tests - Serology

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Protocol Number
Item
Protocol Number
integer
Subject Number
Item
Subject Number
integer
Item
Visit
text
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
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
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
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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