Development and introduction of a ready-to-use pediatric pentavalent vaccine to meet and sustain the needs of developing countries - Quinvaxem®: The first 5 years

Quinvaxem (R) injection (DTwP-HepB-Hib fully-liquid combined vaccine) is a ready-to-use, preservative-free, fully-liquid combined vaccine containing diphtheria and tetanus toxoids, Bordetella pertussis inactivated cellular suspension, hepatitis B surface antigen (HBsAg), and Haemophilus influenzae type b conjugated oligosaccharide. The vaccine was the first ready-to-use, fully-liquid pentavalent vaccine to gain WHO pre-qualification status in 2006. The immunogenicity and safety of Quinvaxem (R) was assessed in four clinical trials and a large post-marketing surveillance study. Quinvaxem (R) was found to be highly immunogenic in each of the primary vaccination studies and was also shown to be suitable as a booster with the advantage that it could be given concomitantly with measles vaccine. Quinvaxem (R) has become a cornerstone in EPI vaccination programs. To further support the needs of EPI vaccination processes and developing countries, a simple, all-in-one, compact, prefilled, auto-disabled Uniject (R) injection system has been chosen and optimized as a potential new presentation for Quinvaxem (R). Hopefully, Quinvaxem (R) in the Uniject (R) presentation will help vaccination programs in developing countries to achieve more. (C) 2012 Elsevier Ltd. All rights reserved.