Safety of the 11-valent pneumococcal vaccine conjugated to non-typeableHaemophilus influenzae-derived protein D in the first 2 years of life and immunogenicity of the co-administered hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio virus,Haemophilus influenzaetype b and control hepatitis A vaccines

• Published in: Vaccine Vol. 26; no. 35; p. 4563
• Main Authors: Prymula, Roman, Chlibek, Roman, Splino, Miroslav, Kaliskova, Eva, Kohl, Igor, Lommel, Patricia, Schuerman, Lode
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Limited 18.08.2008
• Subjects: Age; Antigens; Diphtheria; Ear diseases; Fever; Hepatitis; Immune response; Immunization; Immunogenicity; Infants; Licenses; Pediatrics; Proteins; Tetanus; Vaccines; Viral infections; Whooping cough
• DOI: 10.1016/j.vaccine.2008.05.080
• ISSN: 0264-410X

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 >=15mIU/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.