SAN DIEGO, CA— At IDWeek 2012, study researchers presented data showing that MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, has been shown to be highly immunogenic and well tolerated across age groups.
Tatjana Odrljin, MD, from Novartis Vaccines and Diagnostics, Cambridge, MA, and colleagues conducted a Phase 3 study to assess the immunogenicity and safety of MenACWY-CRM given at 2, 4, 6, and 12 months of age and to demonstrate non-interference with routine infant/toddler vaccines. This open-label, multicenter study randomized 529 infants (aged 55–89 months) 1:1 to MenACWY-CRM co-administered with routine vaccines at 2, 4, 6, and 12 months of age (n=258) or routine vaccines alone (n=271). Routine vaccines consisted of diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenza type b combined vaccine; 7-valent pneumococcal conjugate vaccine; hepatitis B virus vaccine; and measles, mumps, and rubella vaccine.
Immune response was assessed via serum bactericidal activity assay with human complement (hSBA) titers >8 at one month after the four-dose series. Seroresponse to diphtheria, tetanus, Hib, hepatitis B, pneumococcal, and pertussis-antigens concomitant vaccines were measured by standard ELISA methods and via a neutralization test for poliovirus.
Data showed that at 13 months, 89–97% of patients who received MenACWY-CRM with routine vaccines achieved hSBA titers >8 against the four serogroups, meeting the predefined criteria for adequacy of immune response. At seven months, seroresponse rates for concomitant routine infant vaccines were non-inferior to routine vaccinations alone, except for pertussis antigen FIM, although non-inferiority was achieved in terms of geometric mean concentration (GMC) ratio. In addition, at 13 months, immune responses to pneumococcal conjugate vaccine, as measured by GMC ratio, were non-inferior for all seven serotypes when given with or without MenACWY-CRM.
During the entire study period, the most commonly reported adverse event by preferred term was upper respiratory tract infections (56% and 57% in the MenACWY-CMR and routine groups, respectively).
Dr. Odrljin concluded that, “When administered as a four-dose infant series with routine infant/toddler vaccines, MenACWY-CRM was highly immunogenic and well tolerated.” The team added that there was no evidence of clinically significant interference and the safety profiles were similar in those who received routine vaccines with or without MenACWY-CRM.