ID
36775
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 form is to be completed at Visit 3.
Link
https://clinicaltrials.gov/ct2/show/NCT00323622
Keywords
Versions (2)
- 12/12/18 12/12/18 -
- 6/6/19 6/6/19 -
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 3: Study Continuation Check
- StudyEvent: ODM
Description
Check for Study Continuation
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C0805733
Description
If yes, please complete the next pages. If no, please complete below.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0805733
- UMLS CUI [1,3]
- C0008976
Description
withdrawal reason and decision same as previously
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0566251
- UMLS CUI [1,4]
- C2127115
- UMLS CUI [2,1]
- C0422727
- UMLS CUI [2,2]
- C0679006
- UMLS CUI [2,3]
- C2127115
Description
Reason for discontinuation
Data type
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
Description
SAE number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C1519255
Description
specify other reason
Data type
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C1521902
Description
Withdrawal decision
Data type
text
Alias
- UMLS CUI [1,1]
- C0679006
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
Similar models
Visit 3: Study Continuation Check
- StudyEvent: ODM
C0805733 (UMLS CUI-2)
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2127115 (UMLS CUI [1,4])
C0422727 (UMLS CUI [2,1])
C0679006 (UMLS CUI [2,2])
C2127115 (UMLS CUI [2,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])