Tolérance et immunogénicité d’un vaccin pneumococcique osidique conjugué heptavalent (Prevenar ®) administré en association avec une combinaison vaccinale pédiatrique (DTCoq-Polio/Hib) à des nourrissons selon le schéma vaccinal français à l’âge de deux, trois et quatre mois

Abstract

Invasive pneumococcal disease is presently a leading cause of mortality due to bacterial infectious diseases in French children less than 2 years of age, and only the pneumococcal conjugate vaccines induce a protective immune response for those within this vulnerable age group. Material and methods. – The safety and immunogenicity of a heptavalent pneumococcal polysaccharide conjugate vaccine (PREVENAR ®) was tested in French infants immunized with the 2, 3 and 4 month French schedule as part of an open, randomized, comparative clinical study, in association with a whole-cell pertussis-based pediatric combination vaccine. Results. – In the PREVENAR ® plus DTP-IPV/Hib association group, 90.6–100% of children achieved a post-dose three threshold IgG concentration of >0.15 μg/ml against each of the seven pneumococcal serotypes. Regarding immunogenicity, no interference with the antibody response to the various antigenic components of the DTP-IPV/Hib vaccine was observed. Local reactions were significantly less frequent at the PREVENAR ® injection site than at the DTP-IPV/Hib injection site; there was no increase in systemic adverse events in the vaccine association group compared to the DTP-IPV/Hib alone group, further exception of fever >38 °C which was more frequently reported in the PREVENAR + PENTACOQ group following the second dose of vaccines (56% vs. 35%); no serious adverse event could be considered to be related to the PREVENAR ® immunization in this study. Conclusion. – The heptavalent pneumococcal conjugate vaccine is immunogenic when administered at 2, 3 and 4 months. PREVENAR ® can be administered simultaneously with the DTP-IPV/Hib combination vaccine.