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
Phase of Trial: Phase IV
Latest Information Update: 08 Dec 2017
At a glance
- Drugs GSK 257049 (Primary)
- Indications Malaria
- Focus Adverse reactions
- Sponsors GlaxoSmithKline
- 06 Dec 2017 Planned number of patients changed from 47074 to 52192.
- 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.