In 2014, GSK began the regulatory pathway for RTS,S/AS01E (MosquirixTM), the vaccine candidate against malaria for young children living in malaria-endemic areas in sub-Saharan Africa (SSA). Once approved, phase IV clinical studies will run in parallel to the start of the implementation of the vaccine to generate additional safety and impact/effectiveness data.
During the phase III clinical trial, meningitis was identified as a potential risk following immunization with RTS,S/AS01E. Phase IV will describe adverse events of specific interest (AESIs), including meningitis, pre- and post-immunization with MosquirixTM.
AMP is supporting GSK in the development of a sub-study protocol aiming at complementing the phase IV post-licensure safety study EPI-MAL-003, by evaluating the association between MosquirixTM and meningitis in infants and young children in sub-Saharan Africa.