ID

36772

Descrição

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 form is to be completed at/after Visit 3.

Link

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

Palavras-chave

Versões (4)
  1. 12/12/2018 12/12/2018 -
  2. 06/06/2019 06/06/2019 -
  3. 12/06/2019 12/06/2019 -
  4. 27/09/2021 27/09/2021 -
Titular dos direitos

GSK group of companies

Transferido a

6 de junho de 2019

DOI

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Licença

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

Inglês

Visit 3: Laboratory Tests

1 Formulários  
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Blood Sample for Antibodies to CS
Descrição

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?
Descrição

For Cohorts 1 and 2 from Malaria-026

Tipo de dados

boolean

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

if applicable; please complete only if different from visit date

Tipo de dados

date

Alias
UMLS CUI [1]
C1302413
Blood Sample for Antibodies to HBs
Descrição

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?
Descrição

For Cohort 2 only from Malaria-026

Tipo de dados

integer

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

if applicable; please complete only if different from visit date

Tipo de dados

date

Alias
UMLS CUI [1]
C1302413
Blood Sample for Hematocrit
Descrição

Blood Sample for Hematocrit

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0518014
Has a blood sample been taken for hematocrit?
Descrição

blood sample taken for hematocrit

Tipo de dados

boolean

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

if applicable, please complete only if different from visit date

Tipo de dados

date

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

Hematocrit test done

Tipo de dados

boolean

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

if test was done

Tipo de dados

float

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0518014
%
Out of range values
Descrição

if applicable; please enter ONE code

Tipo de dados

integer

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

specification of out of range values

Tipo de dados

text

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

Visit 3: Laboratory Tests

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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?
integer
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])
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