Source: DGNews  |  Posted 1 year ago

NEW YORK -- March 18, 2010 -- The European Commission (EC) has approved a
meningococcal (group A, C, W135 and Y) conjugate vaccine (Menveo) for the
active immunisation of adolescents (from age 11) and adults at risk of exposure
to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease.

Adolescents and young adults are at increased risk of contracting meningococcal
disease, often because they start to encounter new situations and undergo
changes in their lifestyles. Other groups at increased risk of contracting
meningococcal disease include travelers, military personnel, and Muslim
pilgrims traveling to the Hajj or Umrah.

The approval is based on data from a phase 3 clinical trial and a
non-inferiority study. In the non-inferiority study, immune response was
assessed among adolescents aged 11 to 17 years of age.

The vaccine was shown to be non-inferior to a quadrivalent meningococcal
polysaccharide vaccine (ACWY-PS) for all 4 meningococcal groups contained in
the vaccine.

At 1 year after vaccination, a higher proportion of adolescents who received
Menveo had maintained a protective immune response against 3 of the 4
meningococcal groups (groups C, W135, and Y) than those who received ACWY-PS.

When evaluated in adults aged 56 to 65 years, Menveo was shown to be
non-inferior to ACWY-PS in all 4 meningococcal groups contained in the vaccine
and statistically superior for groups A and Y. The clinical significance of
these findings is unknown.

SOURCE: Novartis