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

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...

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Bibliographic Details
Published inVaccine 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
LanguageEnglish
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
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Summary: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.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2008.05.080