A randomized study comparing the safety and immunogenicity of a conjugate vaccine combination containing meningococcal group C and pneumococcal capsular polysaccharide-CRM197 with a meningococcal group C conjugate vaccine in healthy infants: Challenge phase

Abstract

Background: A combination nonavalent pneumococcal-group C meningococcal conjugate vaccine (Pnc9-MenC) was previously found to be safe and immunogenic when administered to infants at 2, 3 and 4 months. This study describes the persistence of immunity at 12 months of age and the immunologic response to a challenge dose of either meningococcal polysaccharide vaccine (Meningivac A + C™; MnA + C), or MenC. Methods: A phase II, randomized, controlled trial of healthy infants. Subjects were given Pnc9-MenC or MenC vaccine at 2, 3 and 4 months of age and then challenged with either MenC or MnA + C. Group C meningococcal immunogenicity was measured by serum bactericidal assay (SBA) and an enzyme-link..