Journal article
Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: A randomised study
J Torresi, LG Heron, M Qiao, J Marjason, L Chambonneau, A Bouckenooghe, M Boaz, D van der Vliet, D Wallace, Y Hutagalung, MD Nissen, PC Richmond
Vaccine | Published : 2015
Abstract
Background: The recombinant yellow fever-17D-dengue virus, live, attenuated, tetravalent dengue vaccine (CYD-TDV) has undergone extensive clinical trials. Here safety and consistency of immunogenicity of phase III manufacturing lots of CYD-TDV were evaluated and compared with a phase II lot and placebo in a dengue-naïve population. Methods: Healthy 18-60 year-olds were randomly assigned in a 3:3:3:3:1 ratio to receive three subcutaneous doses of either CYD-TDV from any one of three phase III lots or a phase II lot, or placebo, respectively in a 0, 6, 12 month dosing schedule. Neutralising antibody geometric mean titres (PRNT50 GMTs) for each of the four dengue serotypes were compared in sera..
View full abstractGrants
Funding Acknowledgements
This study was sponsored by Sanofi Pasteur. The sponsor participated in the trial design and managed all operational aspects of the study, including monitoring data collection, statistical analyses, and writing of the report.