期刊
VACCINE
卷 26, 期 35, 页码 4563-4570出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2008.05.080
关键词
pneumococcal protein D conjugate/DTPa-HBV-IPV/Hib combination vaccines; immunogenicity; safety
资金
- GIaxoSmithKline Biologicals [Undeca-Pn-010/347414/010]
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. (C) 2008 Elsevier Ltd. All rights reserved.
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