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.
Link
https://clinicaltrials.gov/ct2/show/NCT00323622
Keywords
Versions (4)
- 12/11/18 12/11/18 -
- 6/6/19 6/6/19 -
- 6/12/19 6/12/19 -
- 9/27/21 9/27/21 -
Copyright Holder
GSK group of companies
Uploaded on
June 6, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039
Visit 2: Laboratory Tests
- StudyEvent: ODM
Description
Blood Sample for Antibodies to CS
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C3833453
- UMLS CUI-3
- C0525913
Description
For Cohorts 1 and 2 from Malaria-026
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C3833453
- UMLS CUI [1,3]
- C0525913
Description
if applicable; please complete only if different from visit date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Blood Sample for Antibodies to HBs
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0948254
Description
For Cohort 2 only from Malaria-026
Data type
text
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0948254
Description
if applicable; please complete only if different from visit date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Blood Sample for Hematocrit
Alias
- UMLS CUI-1
- C0005834
- UMLS CUI-2
- C0518014
Description
blood sample taken for hematocrit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0518014
Description
if applicable, please complete only if different from visit date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Hematocrit test done
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0518014
- UMLS CUI [1,2]
- C0884358
Description
if test was done
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0518014
Description
if applicable; please enter ONE code
Data type
integer
Alias
- UMLS CUI [1,1]
- C0438215
- UMLS CUI [1,2]
- C0600091
Description
specification of out of range values
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0438215
Similar models
Visit 2: Laboratory Tests
- StudyEvent: ODM
C3833453 (UMLS CUI-2)
C0525913 (UMLS CUI-3)
C3833453 (UMLS CUI [1,2])
C0525913 (UMLS CUI [1,3])
C0948254 (UMLS CUI-2)
C0948254 (UMLS CUI [1,2])
C0518014 (UMLS CUI-2)
C0518014 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,2])