Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus 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 influenzae type b and control hepatitis A vaccines

• Published in: Vaccine 2008-08, Vol.26 (35), p.4563-4570
• Main Authors: Prymula, Roman, Chlibek, Roman, Splino, Miroslav, Kaliskova, Eva, Kohl, Igor, Lommel, Patricia, Schuerman, Lode
• Format: Article
• Language: English
• Subjects: Allergy and Immunology; Antibodies, Bacterial - blood; Applied microbiology; Bacterial diseases; Bacterial Proteins - immunology; Bacteriology; Biological and medical sciences; Carrier Proteins - immunology; Double-Blind Method; Ent and stomatologic bacterial diseases; Female; Fundamental and applied biological sciences. Psychology; Haemophilus Vaccines - adverse effects; Hepatitis A Vaccines - immunology; Human bacterial diseases; Humans; Immunization, Secondary; Immunogenicity; Immunoglobulin D - immunology; Infant; Infectious diseases; Lipoproteins - immunology; Male; Medical sciences; Microbiology; Miscellaneous; Pneumococcal protein D conjugate/DTPa–HBV–IPV/Hib combination vaccines; Pneumococcal Vaccines - adverse effects; Safety; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Conjugate - immunology; Virology
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2008.05.080

Abstract 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.