ID
36745
Beskrivning
An open Phase 2 study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A (SB257049) in Mozambican children aged 1 to 4 years at the time of first vaccine dose. 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 Visit 1.
Länk
https://clinicaltrials.gov/ct2/show/NCT00323622
Nyckelord
Versioner (3)
- 2018-12-11 2018-12-11 -
- 2019-06-05 2019-06-05 -
- 2019-06-06 2019-06-06 - Sarah Riepenhausen
Rättsinnehavare
GSK group of companies
Uppladdad den
5 juni 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039
Visit 1: Eligibility Criteria
- StudyEvent: ODM
Beskrivning
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Beskrivning
If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1516637
- UMLS CUI [1,2]
- C1550543
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
Completion of last visit of previous study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0805732
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C2242969
Beskrivning
Informed Consent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Planned use of investigational or non-registered drug/vaccine during study period
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1301732
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0013230
- UMLS CUI [1,4]
- C0347984
- UMLS CUI [1,5]
- C2347804
- UMLS CUI [2,1]
- C1301732
- UMLS CUI [2,2]
- C1524063
- UMLS CUI [2,3]
- C1517586
- UMLS CUI [2,4]
- C0042210
- UMLS CUI [2,5]
- C0347984
- UMLS CUI [2,6]
- C2347804
Beskrivning
Simultaneous other clinical trial
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348568
Similar models
Visit 1: Eligibility Criteria
- StudyEvent: ODM
C1550543 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C2242969 (UMLS CUI [1,4])
C1524063 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
C1301732 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
C0042210 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
C2347804 (UMLS CUI [2,6])
C2348568 (UMLS CUI [1,2])