ID
33543
Beschreibung
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
Stichworte
Versionen (3)
- 12.12.18 12.12.18 -
- 06.06.19 06.06.19 -
- 12.06.19 12.06.19 -
Rechteinhaber
GSK group of companies
Hochgeladen am
12. Dezember 2018
DOI
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Lizenz
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 - Interim Analysis
- StudyEvent: ODM
Beschreibung
Study Conclusion
Beschreibung
SAEs recorded up to visit 7, month 21 of Malaria-026 to be recorded in Malaria-026; SAEs recorded 1 day after Visit 7, month 21 to be recorded in Malaria-039 SAE forms.
Datentyp
boolean
Beschreibung
Total number of SAEs for the Malaria 039 period only
Datentyp
integer
Beschreibung
Subject Withdrawal
Beschreibung
A subject is withdrawn from the interim analysis if he/she did not come for the interim analysis timepoint visit
Datentyp
boolean
Beschreibung
tick one box only
Datentyp
text
Beschreibung
In case of death, please specify SAE number
Datentyp
integer
Beschreibung
In case of serious adverse event, specify SAE number
Datentyp
integer
Beschreibung
In case of protocol violation, specify
Datentyp
text
Beschreibung
In other cases, specify
Datentyp
text
Beschreibung
Who made the decision
Datentyp
text
Beschreibung
Date of last contact
Datentyp
date
Beschreibung
Was the subject in good condition at date of last contact?
Datentyp
text
Beschreibung
Investigator's Signature
Beschreibung
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Datentyp
date
Beschreibung
Investigator's signature
Datentyp
text
Beschreibung
Investigator's name (in print)
Datentyp
text
Ähnliche Modelle
Study Conclusion - Interim Analysis
- StudyEvent: ODM