New study results show that Menveo was well-tolerated and generated high levels of immunogenicity in infants against meningococcal serogroups A, C, W-135 and Y with a standard infant vaccination dosing schedule.
The Phase II randomized, open-label trial included 421 infants from the UK and Canada and evaluated multiple schedules including two 3-dose primary schedules, at either two, three and four months and two, four and six months. Some participants received either an additional dose of MenACWY-CRM or a plain meningococcal polysaccharide at 12 months. One month after the last primary immunization, the percentage of participants with hSBA titers greater than or equal to 1:4 in the two, three, four-month group was 93% or above for all four serogroups. Immunization at two, four and six months resulted in a similarly high percentage of participants achieving immune response for serogroups C, W-135 and Y, and 81% for serogroup A. The dose at 12 months generated a strong immune response across all four serogroups, was shown to increase levels of immunity, and is likely to provide sustained protection.
Novartis plans regulatory submissions for Menveo in the EU and the US in 2008.
Andrew Pollard, study investigator, said: “These important data show that this new MenACWY vaccine has the potential to protect infants as part of the routine infant vaccine schedule, expanding the potential serogroup coverage of currently available vaccines.”