Safety and immunogenicity of an investigational quadrivalent meningococcal conjugate vaccine after one or two doses given to infants and toddlers
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With the emergence of multiple meningococcal serogroups in different geographic areas, broad vaccine protection from infancy is desirable. One hundred and seventy-five infants received either two doses of a meningococcal quadrivalent (A, C, W-135, Y) conjugate vaccine (MenACWY-CRM) at 6 and 12 months, one dose of MenACWY-CRM at 12 months, or MenC at 12 months and MenACWY-CRM at 18 months. Bactericidal antibody titers using human complement were measured before and 1 month after each dose. Injection-site reactions were reported by 22–45% of participants following MenACWY-CRM given at 6 or 12 months. Similar proportions of subjects had injection-site reactions following two doses of MenACWY-CRM (32–41%) or one dose of MenC (26–44%). The incidence of systemic adverse events was comparable between groups. After two doses of MenACWY-CRM, the percentages of participants reporting hSBA titers ≥8 were 100% for C, W-135, and Y, and 84% for A. Serogroup C titers were more than 10-fold higher after two doses of MenACWY-CRM than after one dose of MenC or MenACWY-CRM at 12 months. Serogroup C titers were comparable following a single dose of MenACWY-CRM or MenC at 12 months. MenACWY-CRM is well tolerated and immunogenic given at 12 months, or two doses at 6 and 12 months of age.
We thank the nurses and staff for their careful attention to detail and to the children and their families for participating in the study. We also thank Dr. Bruce Smith at the Canadian Center for Vaccinology for his independent evaluation of the statistical analysis plan and report and statistical analysis.
A. Anemona and P. Dull are employees of Novartis Vaccines. F. Ceddia was an employee of Novartis Vaccines; current address GlaxoSmithKline Biologicals, Rixensart, Belgium. S. Halperin and F. Diaz-Mitoma had no financial interest in the vaccine or its manufacturer, but received research funding to undertake the study.
The study was funded by Novartis Vaccines.
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