Combination vaccines with low dose of hib conjugate

A - Human Necessities – 61 – K

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A61K 39/295 (2006.01)

Patent

CA 2559996

Combination vaccines including antigens for immunising against diphtheria, tetanus, pertussis and Hib are known ('DTP-Hib' vaccines). The invention addresses the need for such vaccines with low doses of Hib antigen, to reduce cost, that do not require reconstitution in the field. Thus the invention provides a combination vaccine comprising antigens for protecting a subject against at least diphtheria, tetanus, pertussis and Hib, wherein: (a) the antigen for protecting against Hib is a conjugate of a Hib capsular saccharide; (b) the concentration of the Hib conjugate in the vaccine is <15 ~g/ml ; and (c) the Hib conjugate has never been lyophilised. Vaccines of the invention have been found to be safe and to be highly immunogenic.

La présente invention a trait à des vaccins de combinaison comportant des antigènes pour la vaccination contre la diphtérie, le tétanos, la coqueluche et le H.influenza type B désignés vaccins DTP-H.influenza type B. L'invention concerne la nécessité pour de tels vaccins à faibles doses d'antigène H.influenza type B, en vue d'en réduire le coût, car ne nécessitant pas de reconstitution lors de son utilisation. L'invention a donc trait à un vaccin de combinaison comportant des antigènes pour la protection d'un sujet contre au moins la diphtérie, le tétanos, la coqueluche et le H.influenza type B, dans lequel . (a) l'antigène pour la protection contre le H.influenza type B est un conjugué d'un saccharide capsulaire de H.influenza type B; (b) la concentration du conjugué H.influenza type B dans le vaccin est inférieure à 15 µg/ml ; et (c) le conjugué H.influenza type B n'a jamais été lyophilisé. Il été démontré que les vaccins de l'invention sont sécurisés et hautement immunogènes.

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