ID
33511
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
Keywords
Versions (3)
- 12/11/18 12/11/18 -
- 6/6/19 6/6/19 -
- 6/12/19 6/12/19 -
Copyright Holder
GSK group of companies
Uploaded on
December 11, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate in Mozambican children (1 to 4 y.o) - 104297 (Malaria039)
Study Conclusion
- StudyEvent: ODM
Description
Occurrence of serious adverse event
Description
SAEs recorded up to Visit 7, Month 21 of Malaria-026 to be recorded in Malaria-026 SAE forms; SAEs recorded 1 day after Visit 7, Month 21 to be recorded in Malaria-039 SAE forms
Data type
boolean
Description
If Yes, specify total number of SAE's for the Malaria-039 period only
Data type
integer
Description
Subject Withdrawal
Description
A subject is withdrawn from interim analysis if he/she did not come for the interim analysis timepoint visit
Data type
boolean
Description
If Yes, choose one reason for withdrawal
Data type
text
Description
If Death, please specify SAE number
Data type
integer
Description
Is Serious Adverse Event, please specify the SAE number
Data type
integer
Description
If Protocol violation, please specify
Data type
text
Description
If Other, please specify
Data type
text
Description
Who made the decision?
Data type
text
Description
Date of last contact
Data type
date
Description
Was the subject in good condition at date of last contact?
Data type
boolean
Description
If No, please give details in Adverse Event section.
Data type
text
Description
Investigator's Signature
Description
Investigator's confirmation
Data type
date
Description
Investigator's signature
Data type
text
Description
Investigator's name (in print)
Data type
text
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Study Conclusion
- StudyEvent: ODM