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(®) 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(®) was assessed in four clinical trials and a large post-marketing surveillance study. Quinvaxem(®) 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(®) 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(®) injection system has been chosen and optimized as a potential new presentation for Quinvaxem(®). Hopefully, Quinvaxem(®) in the Uniject(®) presentation will help vaccination programs in developing countries to achieve more.
Crucell Switzerland AG, Rehhagstrasse 79, CH-3018 Bern, Switzerland. daphne.schmid@crucell.ch
D A
DA
Schmid
A
A
Macura-Biegun
M
M
Rauscher
D002986:Clinical Trials as Topic; D003906:Developing Countries; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000266:history / Q000276:immunology*; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000266:history / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000266:history / Q000276:immunology*; D049674:History, 21st Century; D006801:Humans; D017589:Immunization Programs / Q000458:organization & administration; D011358:Product Surveillance, Postmarketing; D014611:Vaccination / Q000379:methods*
D015721:Diphtheria-Tetanus-Pertussis Vaccine; C524361:DtwP-HepB-Hib vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines