ID
36768
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 2.
Link
https://clinicaltrials.gov/ct2/show/NCT00323622
Keywords
Versions (2)
- 12/11/18 12/11/18 -
- 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 2: 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 tick the ONE most appropriate reason and skip the following pages of this visit, and please tick who took the decision.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0805733
- UMLS CUI [1,3]
- C0008976
Description
Reason for discontinuation
Data type
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
Description
complete the Serious Adverse Event form
Data type
integer
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C1519255
Description
e.g.: consent withdrawal, Protocol violation, non-serious adverse event …
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
Discontinuation decision
Data type
text
Alias
- UMLS CUI [1,1]
- C0679006
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
Similar models
Visit 2: Study Continuation Check
- StudyEvent: ODM
C0805733 (UMLS CUI-2)
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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])