# name
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

# metadata.dc.description.abstract[].value
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\xC2\xA0months)
                and 6537 infants (enrolled at 6-12\xC2\xA0weeks) 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
                \xE2\x89\xA42 (cerebral malaria [CM]) and gender-specific
                mortality were assessed post-hoc. Serious adverse event (SAE)
                and fatal SAE incidences throughout the study were 24.2%-28.4%
                and 1.5%-2.5%, respectively across groups; 0.0%-0.3% of
                participants reported vaccination-related SAEs. The incidence of
                febrile convulsions in children was higher during the first 2-3
                days post-vaccination with RTS,S/AS01 than with control vaccine,
                consistent with the time window of post-vaccination febrile
                reactions in this study (mostly the day after vaccination). A
                statistically significant numerical imbalance was observed for
                meningitis cases in children (R3R: 11, R3C: 10, C3C: 1) but not
                in infants. CM cases were more frequent in RTS,S/AS01-vaccinated
                children (R3R: 19, R3C: 24, C3C: 10) but not in infants.
                All-cause mortality was higher in RTS,S/AS01-vaccinated versus
                control girls (2.4% vs 1.3%, all ages) in our setting with low
                overall mortality. The observed meningitis and CM signals are
                considered likely chance findings, that - given their severity -
                warrant further evaluation in phase IV studies and WHO-led pilot
                implementation programs to establish the RTS,S/AS01 benefit-risk
                profile in real-life settings.

# metadata.dc.relation.ispartof[].value
Human Vaccines & Immunotherapeutics, 2019

# metadata.dc.rights[].value
cc by (c) GlaxoSmithKline Biologicals S. A., 2019

# metadata.dc.source[].value
Articles publicats en revistes (ISGlobal)

# metadata.dc.title[].value
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