title: The RTS,S/AS01 malaria vaccine in children 5 to 17 months of age at first vaccination.
abstract: The RTS,S/AS01 malaria vaccine received a positive scientific opinion from the European Medicines Agency in July 2015. The World Health Organization recommended pilot implementation of the vaccine in children at least 5 months of age according to an initial 3-dose schedule given at least 1 month apart, and a 4th dose 15-18 months post-dose 3. Clinical trials and mathematical modeling demonstrated that the partial protection provided by RTS,S/AS01 against malaria has the potential to provide substantial public health benefit when used in parallel with other malaria interventions, especially in highly endemic regions. The highest impact was seen with 4 vaccine doses in children aged 5 months or older. The vaccine will be evaluated in real-life settings to further assess its impact on mortality, vaccine safety in the context of routine immunization, and programmatic feasibility of delivering a 4-dose vaccination schedule requiring new immunization contacts. If successful, this will pave the way for larger-scale implementation.
authors.affiliation: a Global Regulatory Affairs, GSK Vaccines , Wavre , Belgium.
authors.forename: Pascale
authors.initials: P
authors.lastname: Vandoolaeghe
authors.affiliation: b Global Medical Affairs, GSK Vaccines , Wavre , Belgium.
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman
mesh_terms: D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008288:Malaria / Q000517:prevention & control*; D017780:Malaria Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D014614:Vaccines, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*
chemical_list: D017780:Malaria Vaccines; C577001:RTS,S-AS01 vaccine; D014614:Vaccines, Synthetic
keywords: Malaria; P. falciparum; RTS,S/AS01; safety; vaccine efficacy