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Nimenrix: new conjugate meningitis vaccine

02 July 2012, 9:18am

Nimenrix is now available for active immunisation against invasive disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

Nimenrix is the first quadrivalent meningococcal conjugate vaccine that is approved for use from 1 year of age

Nimenrix is the first quadrivalent meningococcal conjugate vaccine that is approved for use from 1 year of age

PHARMACOLOGY

Nimenrix is a conjugated quadrivalent meningitis vaccine consisting of four capsular polysaccharide groups conjugated to tetanus toxoid carrier protein. It induces the production of antibodies against capsular polysaccharides of Neisseria meningitidis group A, C, W135 and Y. These antibodies protect against meningococcal disease via complement-mediated bactericidal activity.1

CLINICAL STUDIES

The safety and efficacy of Nimenrix have been evaluated in 17 clinical studies conducted in 17 countries worldwide. Immunogenicity was assessed in six key studies: two studies recruited infants 12–23 months, two studies enrolled children aged 2–10 years of age, and two studies enlisted adolescents aged 11–17 years and adults aged 18–55 years.1

These key studies aimed to demonstrate a non-inferior immunological response to a single dose of Nimenrix compared with a licensed meningococcal vaccine. Serum bactericidal antibody levels were measured by assays using either rabbit or human complement (rSBA or hSBA).1

In all studies, Nimenrix was found to be non-inferior to a licensed meningococcal vaccine in eliciting an immunological response.1

The safety profile of Nimenrix is based on clinical studies involving more than 8,000 patients. The vaccine was generally well tolerated, with the most commonly observed adverse effects including anorexia, irritability, fatigue, drowsiness, headache, fever and injection-site reactions.1

References:

  1. Nimenrix Summary of Product Characteristics, April 2012.

View Nimenrix drug record

Further information: GlaxoSmithKline

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