Abstract

Safety profile of the RTS,S/AS01 malaria vaccine in infants and children: additional data from a phase III randomized controlled trial in sub-Saharan Africa

Guerra Mendoza Y Garric E Leach A Lievens M Ofori-Anyinam O Pircon JY Stegmann JU Vandoolaeghe P Otieno L Otieno W Owusu-Agyei S Sacarlal J Masoud NS Sorgho H Tanner M Tinto H Valea I Mtoro AT Njuguna P Oneko M Otieno GA Otieno K Gesase S Hamel MJ Hoffman I Kaali S Kamthunzi P Kremsner P Lanaspa M Lell B Lusingu J Malabeja A Aide P Akoo P Ansong D Asante KP Berkley JA Adjei S Agbenyega T Agnandji ST Schuerman L
Hum Vaccin Immunother. 2019;152386-2398

Permenent descriptor

A phase III, double-blind, randomized, controlled trial (NCT00866619) in sub-Saharan Africa showed RTS,S/AS01 vaccine efficacy against malaria. We now present in-depth safety results from this study. 8922 children (enrolled at 5-17 months) and 6537 infants (enrolled at 6-12 weeks) were 1:1:1-randomized to receive 4 doses of RTS,S/AS01 (R3R) or non-malaria control vaccine (C3C), or 3 RTS,S/AS01 doses plus control (R3C). Aggregate safety data were reviewed by a multi-functional team. Severe malaria with Blantyre Coma Score