, Volume 72, Issue 18, pp 2407-2430

Meningococcal Quadrivalent (Serogroups A, C, W135 and Y) Tetanus Toxoid Conjugate Vaccine (Nimenrix™)

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Abstract

Nimenrix™ (MenACWY-TT) is a quadrivalent meningococcal conjugate vaccine, comprising the polysaccharide serogroups A, C, W135 and Y, and tetanus toxoid (TT) as carrier protein. It is the first quadrivalent vaccine (administered as a single dose) to be approved in Europe for active immunization of individuals aged ≥12 months against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W135 and Y.

Administration of a single dose of Nimenrix™ elicited a strong immune response against all four vaccine serogroups in healthy toddlers aged 12’23 months, children and adolescents aged 2’17 years and adults aged 18’55 years in randomized, multicentre, phase III trials. In toddlers, Nimenrix™ was noninferior to Meningitec® in terms of seroresponse rates against meningococcal serogroup C 42 days post-vaccination. In children, adolescents and adults, Nimenrix™ was noninferior to Mencevax™ in terms of vaccination response rates against all four serogroups 1 month post-vaccination. Furthermore, several phase II studies and a phase III trial showed that the immune response elicited by Nimenrix™ in all age groups persisted for 7–42 months after the primary vaccination (when evaluated by rabbit serum bactericidal activity), with the vaccine also inducing immune memory in toddlers. In addition, several randomized, multicentre, phase III, noninferiority trials showed that when coadministered with other childhood vaccines or a seasonal flu vaccine, the immunogenicity of Nimenrix™ or that of the coadministered vaccine was generally not altered.

Nimenrix® was generally well tolerated in all age groups whether administered as a single vaccine or coadministered with other routine vaccines. The incidence of grade 3 local or systemic solicited adverse events during the first 4 days following vaccination and of serious adverse events over an extended follow-up period of up to 6 months was low (<4.5%).

Although protective effectiveness and longer-term persistence studies are required, current evidence suggests that Nimenrix™, administered as a single dose, provides a valuable vaccination option for the prevention of meningococcal disease across a broad age group, including children as young as 12 months.

Various sections of the manuscript reviewed by:J. Findlow, Manchester Royal Infirmary, Health Protection Agency, Manchester, UK; S.R. Kimmel, Family Medicine, University of Toledo College of Medicine, Toledo, OH, USA; P. Kriz, Center for Epidemiology and Microbiology, National Institute of Public Health, Prague, Czech Republic; D. Pace, Department of Paediatrics, Mater Dei Hospital, Msida, Malta.

Data Selection

Sources: Medical literature (including published and unpublished data) on ‘Nimenrix’ was identified by searching databases (including MEDLINE and EMBASE) for articles published since 1996, bibliographies from published literature, clinical trial registries/databases and websites (including those of regional regulatory agencies and the manufacturer). Additional information (including contributory unpublished data) was also requested from the company developing the drug.
Search strategy: MEDLINE and EMBASE search terms were ‘Nimenrix’ and (‘meningococcal-vaccine-groups-A-C-Y-W-135-conjugate’ or ‘quadrivalent-meningococcal-conjugate-vaccine’ or ‘tetravalent-meningococcal-conjugate-vaccine’). Searches were last updated 9 November 2012.
Selection: Studies in healthy individuals who received Nimenrix™ for active immunization against invasive disease caused by Neisseria meningitidis. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred.
Index terms: Nimenrix, MenACWY-TT, meningococcal conjugate vaccine, immunogenicity, tolerability.