Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus influenzae

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• 作者：Roman Prymula ; Roman Chlibek ; Miroslav Splino ; Eva Kaliskova ; Igor Kohl ; Patricia Lommel ; Lode Schuerman
• 关键词：Pneumococcal protein D conjugate/DTPa– ; HBV– ; IPV/Hib combination vaccines ; Immunogenicity ; Safety
• 刊名：Vaccine
• 出版年：2008
• 出版时间：18 August 2008
• 年：2008
• 卷：26
• 期：35
• 页码：4563-4570
• 全文大小：325 K

文摘

This randomized (1:1), double-blind, multicenter study, included 4968 healthy infants to receive either the 11-valent pneumococcal protein D (PD)-conjugate study vaccine or the hepatitis A vaccine (HAV) (control) at 3, 4, 5, and 12–15 months of age. The three-dose primary course of both vaccines was co-administered with combined hexavalent DTPa–HBV–IPV/Hib vaccine. The pneumococcal PD-conjugate study vaccine did not impact the immune response of co-administered hexavalent vaccine and the control HAV vaccine induced seropositivity (antibodies ≥15 mIU/mL) in all infants. The incidence of solicited symptoms was higher with the 11-valent pneumococcal PD-conjugate study vaccine, yet similar to that induced by concomitant DTPa–HBV–IPV/Hib vaccine. Overall, the reactogenicity and safety profile of the 11-valent pneumococcal PD-conjugate vaccine when co-administered with the hexavalent DTPa–HBV–IPV/Hib vaccine, as well as the immunogenicity of the co-administered hexavalent vaccine, were consistent with previous reports for the licensed DTPa–HBV–IPV/Hib and pneumococcal conjugate vaccines.