Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM197 in United States infants.
To determine the safety and immunogenicity of heptavalent pneumococcal saccharide vaccine (serotypes 4,6B, 9V, 14,18C, 19F, 23F) individually conjugated to CRM197 (PNCRM7), administered at 2,4,6, and 12 to 15 months of age.
Two hundred twelve healthy 2-month-old infants were equally randomized to receive four consecutive doses of PNCRM7 or an investigational meningococcal group C conjugate vaccine, which served as a control.
Concomitantly administered routine vaccines were oral polio vaccine and combined diphtheria toxoid, tetanus toxoid, and whole cell pertussis vaccine/Haemophilus influenzae type b vaccine consisting of capsular oligosaccharides conjugated to CRM197 (DTP/HbOC) at 2,4, and 6 months, and either measles-mumps-rubella vaccine or HbOC at 12 to 15 months.
Active safety surveillance was conducted for 3 days after each dose.
Antibody concentrations to each of the 7 pneumococcal serotypes were measured by enzyme-linked immunosorbent assay pre-vaccination, after doses two and three, prebooster, and postbooster.
Significantly fewer children experienced local reactions at the PNCRM7 injection site than at the DTP/HbOC site.
There was no increase in the incidence or severity of local reactions at the PNCRM7 site with increasing doses of vaccine.
Mild to moderate postvaccination fever was common in both the PNCRM7 and control vaccine groups, however DTP/HbOC was administered concurrently.
All 7 vaccine serotypes were immunogenic. (...)
Mots-clés Pascal : Vaccination, Etude longitudinale, Association, Réponse immune, Randomisation, Voie abord, Facteur sécurité, Sérotype, Nourrisson, Homme, Immunogénicité, Evaluation, Etats Unis, Amérique du Nord, Amérique, Immunoprophylaxie, Immunologie, PNCRM7 vaccin, Heptavalent pneumococcal vaccine
Mots-clés Pascal anglais : Vaccination, Follow up study, Association, Immune response, Randomization, Surgical approach, Safety factor, Serotype, Infant, Human, Immunogenicity, Evaluation, United States, North America, America, Immunoprophylaxis, Immunology
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0261314
Code Inist : 002B05A02. Création : 11/09/1998.