Pharmacovigilance of malaria intermittent preventive treatment in infants coupled with routine immunizations in 6 African countries.

Background: Intermittent preventive treatment in infants (IPTi) is a new malaria control strategy coupled with the delivery of routine immunizations recommended by the World Health Organization since 2009 for countries with moderate to high endemicity. To evaluate its safety profile and identify potential new adverse events (AEs) following simultaneous administration of sulfadoxine-pyrimethamine (SP-IPTi) with immunizations, we measured AE incidence and evaluated spontaneous AE reporting.

Methods: A cohort event monitoring study was conducted on 24 000 infants in 2 countries after administration of SP-IPTi during routine immunizations.