ID

36765

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.

Lien

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

Mots-clés

Versions (4)
  1. 11/12/2018 11/12/2018 -
  2. 06/06/2019 06/06/2019 -
  3. 12/06/2019 12/06/2019 -
  4. 27/09/2021 27/09/2021 -
Détendeur de droits

GSK group of companies

Téléchargé le

6 juin 2019

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Visit 2: Laboratory Tests

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
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

Type de données

boolean

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

if applicable; please complete only if different from visit date

Type de données

date

Alias
UMLS CUI [1]
C1302413
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

Type de données

text

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

if applicable; please complete only if different from visit date

Type de données

date

Alias
UMLS CUI [1]
C1302413
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

Type de données

boolean

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

if applicable, please complete only if different from visit date

Type de données

date

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

Hematocrit test done

Type de données

boolean

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

if test was done

Type de données

float

Unités de mesure
  • %
Alias
UMLS CUI [1]
C0518014
%
Out of range values
Description

if applicable; please enter ONE code

Type de données

integer

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

specification of out of range values

Type de données

text

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

Visit 2: Laboratory Tests

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (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 sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
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 sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
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 sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
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])
Retour au début de la page 

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