ID
33511
Beskrivning
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
Nyckelord
Versioner (3)
- 2018-12-11 2018-12-11 -
- 2019-06-06 2019-06-06 -
- 2019-06-12 2019-06-12 -
Rättsinnehavare
GSK group of companies
Uppladdad den
11 december 2018
DOI
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Licens
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
Beskrivning
Occurrence of serious adverse event
Beskrivning
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
Datatyp
boolean
Beskrivning
If Yes, specify total number of SAE's for the Malaria-039 period only
Datatyp
integer
Beskrivning
Subject Withdrawal
Beskrivning
A subject is withdrawn from interim analysis if he/she did not come for the interim analysis timepoint visit
Datatyp
boolean
Beskrivning
If Yes, choose one reason for withdrawal
Datatyp
text
Beskrivning
If Death, please specify SAE number
Datatyp
integer
Beskrivning
Is Serious Adverse Event, please specify the SAE number
Datatyp
integer
Beskrivning
If Protocol violation, please specify
Datatyp
text
Beskrivning
If Other, please specify
Datatyp
text
Beskrivning
Who made the decision?
Datatyp
text
Beskrivning
Date of last contact
Datatyp
date
Beskrivning
Was the subject in good condition at date of last contact?
Datatyp
boolean
Beskrivning
If No, please give details in Adverse Event section.
Datatyp
text
Beskrivning
Investigator's Signature
Beskrivning
Investigator's confirmation
Datatyp
date
Beskrivning
Investigator's signature
Datatyp
text
Beskrivning
Investigator's name (in print)
Datatyp
text
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Study Conclusion
- StudyEvent: ODM