Safety and immunogenicity of two doses of quadrivalent meningococcal conjugate vaccine or one dose of meningococcal group C conjugate vaccine, both administered concomitantly with routine immunization to 12- to 18-month-old children

Francisco Noya, Deirdre McCormack, Donna L Reynolds, Dion Neame, Philipp Oster, Francisco Noya, Deirdre McCormack, Donna L Reynolds, Dion Neame, Philipp Oster

Abstract

Objectives: To describe the immunogenicity and safety of a two-dose series of a quadrivalent meningococcal (serogroups A, C, Y and W) polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-D) administered to toddlers.

Methods: Children were randomly assigned (1:1) at study entry to receive MenACYW-D at 12 and 18 months of age (group 1; n=61) or meningococcal serogroup C conjugate vaccine (MCC) at 12 months of age (group 2; n=62). All received routine childhood immunizations. A, C, Y and W antibody titres were measured in group 1 before and one month after the 18-month MenACYW-D vaccination and were measured in group 2 at one and seven months post-MCC vaccination. Antibodies elicited by diphtheria and tetanus toxoids, and acellular pertussis vaccine adsorbed combined with inactivated poliomyelitis vaccine and Haemophilus influenzae b conjugate (DTaP-IPV-Hib) vaccine coadministered at the 18-month vaccination were measured one month later. Safety data were collected.

Results: At 19 months of age, ≥96% in group 1 achieved protective titres for the four meningococcal serogroups after dose 2; 67% in group 2 exhibited protective titres against serogroup C 28 days after MCC vaccination at 12 months of age, declining to 27% seven months later. DTaP-IPV-Hib elicited high antibody concentrations/titres in groups 1 and 2, consistent with historical values. The safety profiles after each dose generated no unexpected safety signals; no serious adverse events were related to vaccination.

Discussion: A two-dose series of MenACYW-D given concomitantly with a DTaP-IPV-Hib booster dose at 18 months of age demonstrated a good immunogenicity and safety profile. A two-dose series of MenACYW-D can be used as an alternative to one dose of MCC and provides protection against additional serogroups (NCT ID: NCT01359449).

Keywords: Canada; Conjugate; Meningococcal; Quadrivalent; Vaccine.

Figures

Figure 1)
Figure 1)
Frequency of solicited adverse reactions according to study group and intensity. ACWY-D Quadrivalent meningococcal conjugate vaccine; MCC Meningococcal conjugate group C vaccine

References

    1. Manchanda V, Gupta S, Bhalla P. Meningococcal disease: History, epidemiology, pathogenesis, clinical manifestations, diagnosis, antimicrobial susceptibility and prevention. Indian J Med Microbiol. 2006;24:7–19.
    1. Harrison OB, Claus H, Jiang Y, et al. Description and nomenclature of Neisseria meningitidis capsule locus. Emerg Infect Dis. 2013;19:566–73.
    1. Pelton SI, Gilmet GP. Expanding prevention of invasive meningococcal disease. Expert Rev Vaccines. 2009;8:717–27.
    1. Kirsch EA, Barton RP, Kitchen L, Giroir BP. Pathophysiology, treatment and outcome of meningococcemia: A review and recent experience. Pediatr Infect Dis J. 1996;15:967–78. quiz 79.
    1. Centers for Disease Control and Prevention (CDC) Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Recomm Rep. 2005;54(RR-7):1–21.
    1. Granoff DM, Pelton S, Harrison D. Meningococcal vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 6th edn. Philadelphia: Saunders Elsevier; 2012. pp. 388–418.
    1. Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease. Vaccine. 2009;27(Suppl 2):B51–63.
    1. Health Canada Web Site. Drugs and Health Products: Bexsero. 2014. < > (Accessed February 26, 2014)
    1. National Advisory Committee on Immunization (NACI) An update on the invasive meningococcal disease and meningococcal vaccine conjugate recommendations. An Advisory Committee Statement (ACS) Can Commun Dis Rep. 2009;35(ACS-3):1–40.
    1. Public Health Agency of Canada (PHAC) Invasive meningococcal disease (IMD) 2012. < > (Accessed July 2, 2013)
    1. Wilder-Smith A, Goh KT, Barkham T, Paton NI. Hajj-associated outbreak strain of Neisseria meningitidis serogroup W135: Estimates of the attack rate in a defined population and the risk of invasive disease developing in carriers. Clin Infect Dis. 2003;36:679–83.
    1. Public Health Agency of Canada (PHAC) Publicly funded immunization programs in Canada – routine schedule for infants and children including special programs and catch-up programs (as of March 2013) 2013. < > (Accessed July 2, 2013)
    1. U.S. National Institutes of Health. Study of two doses of Menactra® or one dose of monovalent meningococcal group C vaccine with routine immunizations. 2013. < > (Accessed July 2, 2013)
    1. Pina LM, Bassily E, Machmer A, Hou V, Reinhardt A. Safety and immunogenicity of a quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine in infants and toddlers: Three multicenter phase III studies. Pediatr Infect Dis J. 2012;31:1173–83.
    1. Grimprel E, Wysocki J, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Immunogenicity and safety of fully liquid DTaP(5)-IPV-Hib compared with DTaP(3)-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: A phase III, single-blind, randomised, controlled, multicentre study. Vaccine. 2011;29:7370–8.
    1. Keyserling HL, Pina M, Hou V, Bassily E, DeTora L, Reinhardt A. Immunogenicity of a quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine against serogroups A, C, Y, and W-135 (MCV-4) in 9- to 15-month olds. Abstract 640. 44th Annual Meeting of the Infectious Disease Society of America (IDSA); Toronto, Ontario. October 12 to 15, 2006.

Source: PubMed

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