ID
33543
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)
- 2018-12-12 2018-12-12 -
- 2019-06-06 2019-06-06 -
- 2019-06-12 2019-06-12 -
Rättsinnehavare
GSK group of companies
Uppladdad den
12 december 2018
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Immunogenicity of malaria vaccine candidate in Mozambican children (1 to 4 y.o) - 104297 (Malaria039)
Study Conclusion - Interim Analysis
- StudyEvent: ODM
Beskrivning
Study Conclusion
Beskrivning
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.
Datatyp
boolean
Beskrivning
Total number of SAEs for the Malaria 039 period only
Datatyp
integer
Beskrivning
Subject Withdrawal
Beskrivning
A subject is withdrawn from the interim analysis if he/she did not come for the interim analysis timepoint visit
Datatyp
boolean
Beskrivning
tick one box only
Datatyp
text
Beskrivning
In case of death, please specify SAE number
Datatyp
integer
Beskrivning
In case of serious adverse event, specify SAE number
Datatyp
integer
Beskrivning
In case of protocol violation, specify
Datatyp
text
Beskrivning
In other cases, 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
text
Beskrivning
Investigator's Signature
Beskrivning
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.
Datatyp
date
Beskrivning
Investigator's signature
Datatyp
text
Beskrivning
Investigator's name (in print)
Datatyp
text
Similar models
Study Conclusion - Interim Analysis
- StudyEvent: ODM