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A randomized, controlled, observer-blind, phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26.RSV.preF in RSV-seronegative toddlers 12 to 24 months of age

Investigators: Beth Arrowsmith, Camille Gibson, Christina Anthony, Fiona McDonald, Jan Jones, Jane Jones, Jennifer Gatens, Jennifer Kent, Krist Ewe, Lisa Montgomery, Nikki Schultz, Peter Richmond, Tanya Stoney

RSV is a respiratory virus that infects the lungs and airways. In children, RSV infection leads to mild to moderate cold-like symptoms. Children generally recover well, however RSV is considered to be the most important cause of serious acute respiratory illness leading to hospitalisation in infants and children under 5 years of age. This study aims to investigate a new vaccine which has been developed to protect children from RSV. We will measure the child's immune response to the vaccine, as well as monitor how well it is tolerated.

Project partner: Janssen Vaccines & Prevention B.V.