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;15

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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