The EU approval is based upon results from a Phase 3, open-label, randomized, controlled study in over 1,000 healthy infants from six weeks of age. The six confirmatory co-primary objectives of the study were met.

Based on clinical evidence, Nimenrix was approved for administration in infants as a two dose primary series, with the first dose given from six weeks of age and with an interval of two months between doses, followed by a booster dose at 12 months.

 Nimenrix is indicated in EU for active immunization of individuals from the age of six weeks and above against invasive meningococcal disease caused by Neisseria meningitidis group A, C, W-135, and Y.

Source: RTT News