ID

33521

Beskrivning

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

Nyckelord

Versioner (4)
  1. 2018-12-11 2018-12-11 -
  2. 2019-06-06 2019-06-06 -
  3. 2019-06-12 2019-06-12 -
  4. 2021-09-27 2021-09-27 -
Rättsinnehavare

GSK group of companies

Uppladdad den

11 december 2018

DOI

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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)

Engelsk

Visit 2: Laboratory Tests - Serology

1 Formulär  
Administrative data
Beskrivning

Administrative data

Protocol Number
Beskrivning

Protocol Number

Datatyp

integer

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Visit
Beskrivning

Visit

Datatyp

text

Blood Sample for Antibodies to CS
Beskrivning

Blood Sample for Antibodies to CS

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

For Cohort 2 only from Malaria-026

Datatyp

boolean

Date sample taken
Beskrivning

Date sample taken

Datatyp

date

Blood Sample for Antibodies to HBs
Beskrivning

Blood Sample for Antibodies to HBs

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

For Cohort 2 only from Malaria-026

Datatyp

text

Date sample taken
Beskrivning

Date sample taken

Datatyp

date

Blood Sample for Hematocrit
Beskrivning

Blood Sample for Hematocrit

Has a blood sample been taken for hematocrit?
Beskrivning

Has a blood sample been taken for hematocrit?

Datatyp

boolean

Date sample taken
Beskrivning

Date sample taken

Datatyp

date

Test
Beskrivning

Test

PCV (Packed cell volume) / Hematocrit
Beskrivning

PCV (Packed cell volume) / Hematocrit

Datatyp

text

Results
Beskrivning

Results

Datatyp

float

Måttenheter
  • %
%
Out of range values
Beskrivning

Out of range values

Datatyp

integer

If Other, please specify
Beskrivning

If Other, please specify

Datatyp

text

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Similar models

Visit 2: Laboratory Tests - Serology

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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