Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine (HibMenCY-TT; MenHibrix ®): A Review
Adis Drug Evaluation
First Online: 07 May 2013 DOI:
Cite this article as: Perry, C.M. Drugs (2013) 73: 703. doi:10.1007/s40265-013-0048-9 Abstract
The meningococcal groups C and Y and Haemophilus b (Hib) tetanus toxoid conjugate vaccine (HibMenCY-TT) contains
Neisseria meningitidis serogroup C and Y capsular polysaccharide antigens, and Hib capsular polysaccharide [polyribosyl-ribitol-phosphate (PRP)]. The HibMenCY-TT vaccine is available in the USA for use as active immunization to prevent invasive disease caused by N. meningitidis serogroups C (MenC) and Y (MenY), and Hib in children 6 weeks–18 months of age. HibMenCY-TT is the first meningococcal vaccine available for use in the USA that can be administered to infants as young as 6 weeks of age. In a randomized, controlled, phase III clinical trial, the HibMenCY-TT vaccine, administered to infants at 2, 4, 6 and 12–15 months of age, was immunogenic against MenC and MenY, and met the prespecified criteria for immunogenicity. Anti-PRP antibodies, which have been shown to correlate with protection against Hib invasive disease, were also induced in the infants who received the HibMenCY-TT vaccine, with induced levels of this antibody noninferior to those occurring in the control group of infants who received a Hib tetanus toxoid conjugate vaccine at 2, 4, and 6 months and a single dose of Hib conjugated to N. meningitidis outer membrane protein at 12–15 months. In several randomized, controlled clinical trials, HibMenCY-TT was coadministered with vaccines that are routinely administered to infants and toddlers in the USA. These vaccines included: diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine combined; 7-valent Streptococcus pneumoniae polysaccharide conjugate vaccine; measles, mumps and rubella vaccine; and varicella vaccine. Coadministration of these vaccines did not interfere with the immunogenicity of the HibMenCY-TT vaccine. Similarly, immune responses to the coadministered vaccines were not affected by the HibMenCY-TT vaccine. The tolerability profile of the HibMenCY-TT vaccine in infants and toddlers in the phase III trial was considered to be clinically acceptable and comparable to that of the Hib conjugate vaccines received by the control group.
The manuscript was reviewed by:
M. Blatter, Primary Physicians Research, Pittsburgh, Pennsylvania, USA; S. Nadel, Paediatric Intensive Care, Department of Medicine, Imperial College, London, England. References
World Health Organization. New and under-utilized vaccines implementation (NUVI). 2012.
. Accessed 22 Mar 2013.
World Health Organization. Bacterial meningitis (including
type b (Hib),
. Accessed 22 Mar 2013.
Girard MP, Preziosi MP, Aguado MT, et al. A review of vaccine research and development: meningococcal disease. Vaccine. 2006;24(22):4692–700.
Brooks R, Woods C, Benjamin D Jr, et al. Increased case-fatality rate associated with outbreaks of
infection, compared with sporadic meningococcal disease, in the United States, 1994–2002. Clin Infect Dis. 2006;43(1):49–54.
Al-Tawfiq JA, Clark TA, Memish ZA. Meningococcal disease: the organism, clinical presentation, and worldwide epidemiology. J Travel Med. 2010;17(Suppl):3–8.
van Deuren M, Brandtzaeg P, van Der Meer J, et al. Update on meningococcal disease with emphasis on pathogenesis and clinical management. Clin Microbiol Rev. 2000;13(1):144–66.
Bryant KA, Marshall GS.
serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011;10(7):941–50.
Khatami A, Pollard AJ. The epidemiology of meningococcal disease and the impact of vaccines. Expert Rev Vaccines. 2010;9(3):285–98.
Cohn AC, MacNeil JR, Harrison LH. Changes in
disease epidemiology in the United States 1998–2007: implications for prevention of meningococcal disease. Clin Infect Dis. 2010;50(2):184–91.
Harrison LH, Pelton SI, Wilder-Smith A, et al. The global meningococcal initiative: recommendations for reducing the global burden of meningococcal disease. Vaccine. 2011;29(18):3363–71.
Harrison LH. Epidemiological profile of meningococcal disease in the United States. Clin Infect Dis. 2010;50(2):S37–44.
Hausdorff WP, Hajjeh R, Al-Mazrou A, et al. The epidemiology of pneumococcal, meningococcal, and Haemophilus disease in the Middle East and North Africa (MENA) region—current status and needs. Vaccine. 2007;25(11):1935–44.
Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease. Vaccine. 2009;27(Suppl. 2):B51–63.
GlaxoSmithKline. GSK Receives FDA Approval for MenHibrix. 2012.
. Accessed 22 Mar 2013.
Marshall GS. Perspectives on immunization. J Manag Care Med. 2012;15(3):5–10.
Richmond P, Kaczmarski E, Borrow R, et al. Meningococcal C polysaccharide vaccine induces immunologic hyporesponsiveness in adults that is overcome by meningococcal C conjugate vaccine. J Infect Dis. 2000;181(2):761–4.
Harrison LH. Prospects for vaccine prevention of meningococcal infection. Clin Microbiol Rev. 2006;19(1):142–64.
Granoff DM, Gupta RK, Belshe RB, et al. Induction of immunologic refractoriness in adults by meningococcal C polysaccharide vaccination. J Infect Dis. 1998;178(3):870–4.
Broker M, Veitch K. Quadrivalent meningococcal vaccines: hyporesponsiveness as an important consideration when choosing between the use of conjugate vaccine or polysaccharide vaccine. Travel Med Infect Dis. 2010;8(1):47–50.
Miller JM, Mesaros N, Van Der Wielen M, et al. Conjugate meningococcal vaccines development: GSK biologicals experience. Adv Prev Med. 2011;Article ID 846756.
Centers for Disease Control and Prevention (CDC). Updated recommendations for the use of meningococcal conjugate vaccines—Advisory Committee on Immunization Practices (ACIP), 2010. Morbidity and Mortality Weekly Report (MMWR). 2011;60:72–6.
Croxtall J, Dhillon S. Meningococcal quadrivalent (serogroups A, C, W135 and Y) tetanus toxoid conjugate vaccine (Nimenrix
). Drugs. 2012;72(18):2407–30.
Bryant KA, Marshall GS, Marchant CD, et al. Immunogenicity and safety of H influenzae type b-N meningitidis C/Y conjugate vaccine in infants. Pediatrics. 2011;127(6):e1375–85.
GlaxoSmithKline. US prescribing information for MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) 2012.
. Accessed 22 Mar 2013.
Centers for Disease Control and Prevention (CDC). Infant meningococcal vaccination: Advisory Committee on Immunization Practices (ACIP) recommendations and rationale. MMWR Morb Mortal Wkly Rep. 2013;62:52–4.
Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129:1307–26.
Robbins JB, Parke JC, Schneerson R, et al. Quantitative measurement of “natural” and immunization-induced
Haemophilus influenzae type b capsular polysaccharide antibodies. Pediatr Res. 1973;7:103–10.
Peltola H, Käythy H, Sivonen A, et al.
type b capsular polysaccharide vaccine in children: a double-blind field study of 100,000 vaccinees 3 months to 5 years of age in Finland. Pediatrics. 1977;60:730–7.
Anderson P. The protective level of serum antibodies to the capsular polysaccharide of
Haemophilus influenzae type b. J Infect Dis. 1984;149:1034–5.
Käythy H, Peltola H, Karanko V, et al. The protective level of serum antibodies to the capsular polysaccharide of
type b. J Infect Dis. 1983;147:1100.
Nolan T, Lambert S, Roberton D, et al. A novel combined
serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine. 2007;25(51):8487–99.
Nolan T, Richmond P, Marshall H, et al. Immunogenicity and safety of an investigational combined
serogroups C and Y-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2011;30(3):190–6.
Habermehl P, Leroux-Roels G, Sanger R, et al. Combined
Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2, 3, 4 months schedule with a fourth dose at 12–18 months of age. Hum. 2010;6(8):640–51.
Marchant CD, Miller JM, Marshall GS, et al. Randomized trial to assess immunogenicity and safety of
type b and
serogroups C and Y-tetanus toxoid conjugate vaccine in infants. Pediatr Infect Dis J. 2010;29(1):48–52.
Marshall GS, Marchant CD, Blatter M, et al. Immune response and one-year antibody persistence after a fourth dose of a novel
type b and
serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 2010;29(5):469–71.
Marshall GS, Mesaros N, Aris E, et al. Persistence of immunity three years after an investigational
haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y tetanus toxoid (HibMenCY-TT) conjugate vaccine (abstract no. 25219). In: Proceedings of the 45th National Immunization Conference, Washington, DC; 28–31 Mar 2011.
Marshall G, Blatter M, Marchant C, et al. Antibody persistence for up to 5 years after a fourth dose of
type B and
serogroups C and Y-Tetanus Toxoid conjugate vaccine (Hibmency-TT) given at 12–15 months. Pediatr Infect Dis J. 2013. doi:
Marshall GS, Marchant CD, Blatter M, et al. Co-administration of a novel
type b and
serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States. Human Vaccines. 2011;7(2):258–64.
Bryant KA, McVernon J, Marchant CD, et al. Immunogenicity and safety of measles–mumps–rubella and varicella vaccines coadminstered with a fourth dose of
Haemophilus influenzae type b and Neisseria meningitidis subgroups C and T-tetanus toxoid conjugate vaccine in toddlers. Human Vaccines Immunother. 2012;8(8):1036–41.
Rinderknecht S, Bryant K, Nolan T, et al. The safety profile of
serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Human Vaccines Immunother. 2012;8(3):294–301.
CrossRef Copyright information
© Springer International Publishing Switzerland 2013