ID

33521

Beschreibung

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

Stichworte

  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 -
Rechteinhaber

GSK group of companies

Hochgeladen am

11. Dezember 2018

DOI

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Lizenz

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
Beschreibung

Administrative data

Protocol Number
Beschreibung

Protocol Number

Datentyp

integer

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Visit
Beschreibung

Visit

Datentyp

text

Blood Sample for Antibodies to CS
Beschreibung

Blood Sample for Antibodies to CS

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

For Cohort 2 only from Malaria-026

Datentyp

boolean

Date sample taken
Beschreibung

Date sample taken

Datentyp

date

Blood Sample for Antibodies to HBs
Beschreibung

Blood Sample for Antibodies to HBs

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

For Cohort 2 only from Malaria-026

Datentyp

text

Date sample taken
Beschreibung

Date sample taken

Datentyp

date

Blood Sample for Hematocrit
Beschreibung

Blood Sample for Hematocrit

Has a blood sample been taken for hematocrit?
Beschreibung

Has a blood sample been taken for hematocrit?

Datentyp

boolean

Date sample taken
Beschreibung

Date sample taken

Datentyp

date

Test
Beschreibung

Test

PCV (Packed cell volume) / Hematocrit
Beschreibung

PCV (Packed cell volume) / Hematocrit

Datentyp

text

Results
Beschreibung

Results

Datentyp

float

Maßeinheiten
  • %
%
Out of range values
Beschreibung

Out of range values

Datentyp

integer

If Other, please specify
Beschreibung

If Other, please specify

Datentyp

text

Ähnliche Modelle

Visit 2: Laboratory Tests - Serology

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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