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

• Main Authors: Yolanda Guerra Mendoza (Author), Elodie Garric (Author), Amanda Leach (Author), Marc Lievens (Author), Opokua Ofori-Anyinam (Author), Jean-Yves Pirçon (Author), Jens-Ulrich Stegmann (Author), Pascale Vandoolaeghe (Author), Lucas Otieno (Author), Walter Otieno (Author), Seth Owusu-Agyei (Author), Jahit Sacarlal (Author), Nahya Salim Masoud (Author), Hermann Sorgho (Author), Marcel Tanner (Author), Halidou Tinto (Author), Innocent Valea (Author), Ali Takadir Mtoro (Author), Patricia Njuguna (Author), Martina Oneko (Author), Godfrey Allan Otieno (Author), Kephas Otieno (Author), Samwel Gesase (Author), Mary J Hamel (Author), Irving Hoffman (Author), Seyram Kaali (Author), Portia Kamthunzi (Author), Peter Kremsner (Author), Miguel Lanaspa (Author), Bertrand Lell (Author), John Lusingu (Author), Anangisye Malabeja (Author), Pedro Aide (Author), Pauline Akoo (Author), Daniel Ansong (Author), Kwaku Poku Asante (Author), James A Berkley (Author), Samuel Adjei (Author), Tsiri Agbenyega (Author), Selidji Todagbe Agnandji (Author), Lode Schuerman (Author)
• Format: Book
• Published: Taylor & Francis Group, 2019-10-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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-randomi...