A Prospective Study to Estimate the Incidence of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Infants and Young Children in Sub-Saharan Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine

Trial Profile

A Prospective Study to Estimate the Incidence of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Infants and Young Children in Sub-Saharan Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine

Recruiting
Phase of Trial: Phase IV

Latest Information Update: 05 Apr 2017

At a glance

  • Drugs GSK 257049 (Primary)
  • Indications Malaria
  • Focus Adverse reactions
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 05 Apr 2017 Protocol of the study amended to change the time frame of primary end points from 24 months to 44 months
    • 30 Mar 2017 Planned number of patients changed from 41024 to 47074.
    • 30 Mar 2017 Planned End Date changed from 1 Feb 2021 to 30 May 2022.
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