NIMENRIX

What it is

NIMENRIX is a sterile solution of Neisseria meningitidis purified capsular polysaccharides of groups A, C, W-135, and Y, individually conjugated to tetanus toxoid protein prepared from cultures of Clostridium tetani. No preservative or adjuvant is added during manufacture. NIMENRIX is a clear, colourless, sterile, preservative-free solution.

Approved indications

— Active immunisation of individuals from 6 weeks of age against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.

Dosing overview

NIMENRIX should be administered as a 0.5 mL single dose injection by the intramuscular route only. For infants from 6 weeks of age, the primary vaccination schedule consists of three doses with an interval of at least 2 months between doses and a fourth dose administered from 12 months of age at least 2 months after the third dose. Infants from 6 months to less than 12 months of age receive two doses with the second dose from 12 months of age and at least 2 months after the first dose. Individuals from 12 months of age and older receive one single dose. NIMENRIX may be given as a single booster dose to adolescents and adults who have previously been primed with meningococcal vaccine at least 3 years prior.

Key safety warnings

Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine. Vaccination with NIMENRIX may not protect all vaccine recipients. NIMENRIX will not protect against N meningitidis serogroup B disease. Immunisation with NIMENRIX does not substitute for routine tetanus immunisation. Waning of serum bactericidal antibody titres against serogroup A when using human complement in the assay (hSBA) has been reported for NIMENRIX and other quadrivalent meningococcal vaccines. The clinical relevance of this observation is unknown. Vaccination should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination. Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to NIMENRIX. Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis, including invasive disease caused by serogroups A, C, W, and Y, even if they develop antibodies following vaccination with NIMENRIX.

Contraindications

NIMENRIX is contraindicated in anyone with a known systemic hypersensitivity reaction to any component of NIMENRIX or after previous administration of the vaccine or a vaccine containing the same components.

PBS listing

In March 2018, PBAC recommended NIMENRIX as a designated vaccine for infants. In August 2018, the PBAC revised its recommendation and advised that NIMENRIX would be acceptably cost-effective at a price that results in a cost per QALY gained of $15,000–45,000 or less.

Regulatory history

NIMENRIX was first listed on the ARTG on 29 August 2013 as a meningococcal (groups A, C, W-135, Y) polysaccharide tetanus toxoid conjugate vaccine injection in a vial and diluent syringe under licence category RE. In March 2018, the PBAC recommended NIMENRIX as a new vaccine for meningococcal disease. An August 2018 PBAC review refined the recommendation regarding cost-effectiveness. NIMENRIX is subject to additional monitoring in Australia.