Safety and immunogenicity of inactivated poliovirus vaccine when given with measles–rubella combined vaccine and yellow fever vaccine and when given via different administration routes: a phase 4, randomised, non-inferiority trial in The Gambia

Publication date: Available online 27 June 2016 Source:The Lancet Global Health Author(s): Ed Clarke, Yauba Saidu, Jane U Adetifa, Ikechukwu Adigweme, Mariama Badjie Hydara, Adedapo O Bashorun, Ngozi Moneke-Anyanwoke, Ama Umesi, Elishia Roberts, Pa Modou Cham, Michael E Okoye, Kevin E Brown, Matthias Niedrig, Panchali Roy Chowdhury, Ralf Clemens, Ananda S Bandyopadhyay, Jenny Mueller, David J Jeffries, Beate Kampmann Background The introduction of the inactivated poliovirus vaccine (IPV) represents a crucial step in the polio eradication endgame. This trial examined the safety and immunogenicity of IPV given alongside the measles–rubella and yellow fever vaccines at 9 months and when given as a full or fractional dose using needle and syringe or disposable-syringe jet injector. Methods We did a phase 4, randomised, non-inferiority trial at three periurban government clinics in west Gambia. Infants aged 9–10 months who had already received oral poliovirus vaccine were randomly assigned to receive the IPV, measles–rubella, and yellow fever vaccines, singularly or in combination. Separately, IPV was given as a full intramuscular or fractional intradermal dose by needle and syringe or disposable-syringe jet injector at a second visit. The primary outcomes were seroprevalence rates for poliovirus 4–6 weeks post-vaccination and the rate of seroconversion between baseline and post-vaccination serum samples for measles, rubella, and...
Source: The Lancet Global Health - Category: Global & Universal Source Type: research