Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.
vials containing powder for reconstitution
Approved indication: prevention of meningococcal disease
Australian Medicines Handbook section 20.1
Meningococcal disease is caused by the Gram-negative bacterium Neisseria meningitidis.The most prevalent disease-causing serogroups are A, B, C, W135 and Y. Asymptomatic carriage of meningococci in the upper respiratory tract is relatively common, but occasionally the bacteria invade and cause septicaemia and meningitis. Infection can be rapid and fatal and mainly affects children under two years. However, there is also a peak of incidence in adolescents associated with increased carriage rates.
Currently in Australia there are two types of meningococcal vaccine – meningococcal C conjugate vaccines and polysaccharide vaccines. The conjugate vaccines consist of serogroup C polysaccharide conjugated to a carrier protein. These vaccines are immunogenic in babies and are given from two months of age. However, they only protect against serogroup C disease. The polysaccharide vaccines contain serogroups A, C, W135 and Y, but because they are not conjugated to protein they may only protect for a short duration, do not induce immunological memory and are relatively ineffective in young children.
This new vaccine is a quadrivalent conjugate vaccine containing oligosaccharides from serogroups A, C, W135 and Y individually attached to Corynebacterium diphtheriae CRM197 protein. In a clinical trial of people aged 11 and over, one intramuscular dose of the vaccine was immunogenic and seemed to be non-inferior to a similar conjugate vaccine (Menactra).1In another trial of 11–17 year olds, the vaccine seemed to be comparable to a quadrivalent polysaccharide vaccine (Menomune).2Adverse events were generally mild and included injection-site reactions, headache, nausea and malaise.
Based on immunological data, this vaccine should protect against meningococcal infections caused by serogroups A, C, W135 and Y. However, it is important to remember that it will not prevent serogroup B disease. The vaccine is currently only indicated for people aged 11 years or older. The US Food and Drug Administration has requested additional safety data in infants before considering approval in this age group.
The Transparency Score ( ) is explained in New drugs: transparency', Vol 37 No 1, Aust Prescr 2014;37:27.
- Reisinger KS, Baxter R, Block SL, Shah J, Bedell L, Dull PM. Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra. Clin Vaccine Immunol 2009;16:1810-15.
- Jackson LA, Jacobson RM, Reisinger KS, Anemona A, Danzig LE, Dull PM. A randomized trial to determine the tolerability and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine in healthy adolescents. Pediatr Infect Dis 2009;28:86-91.