MenQuadfi

What it is

MenQuadfi 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. MenQuadfi is a clear, colourless, sterile, preservative-free solution. Each 0.5 mL dose of vaccine contains meningococcal polysaccharide group A 10.0 micrograms per dose, group C 10.0 micrograms per dose, group Y 10.0 micrograms per dose, and group W-135 10.0 micrograms per dose, with each of the four polysaccharides conjugated to tetanus toxoid (approximately 55 micrograms per dose).

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

MenQuadfi should be administered as a 0.5 mL single dose injection by the intramuscular route only. Primary vaccination in infants from 6 weeks of age requires 3 doses with an interval of at least 2 months between doses and a 4th 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 require 2 doses with the 2nd dose from 12 months of age and at least 2 months after the first dose. Individuals from 12 months of age and older require one single dose. MenQuadfi 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. As with any vaccine, vaccination with MenQuadfi may not protect all vaccine recipients. MenQuadfi will not protect against N meningitidis serogroup B disease. Immunisation with MenQuadfi 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 MenQuadfi and other quadrivalent meningococcal vaccines. The clinical relevance of this observation is unknown. 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 MenQuadfi.

Contraindications

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

PBS listing

MenQuadfi is registered on the ARTG as meningococcal (groups A, C, Y, W) polysaccharide tetanus toxoid conjugate vaccine, solution for injection, vial. MenQuadfi was recommended by the PBAC in November 2020 for prevention of meningococcal disease, with a further positive recommendation in March 2023.

Regulatory history

MenQuadfi was first listed on the ARTG on 29 October 2020. Regulatory approval was granted on 27 October 2020 for active immunisation for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y. The PBAC recommended listing in November 2020 and again recommended listing in March 2023, noting that a positive recommendation from March 2021 had been extended for 12 months. MenQuadfi is subject to additional monitoring in Australia, which will allow quick identification of new safety information.