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A Licensed Combined Haemophilus influenzae Type b-Serogroups C and Y Meningococcal Conjugate Vaccine
Kirsten P Perrett1, Terry M Nolan, Jodie McVernon
1Vaccine and Immunisation Research Group, Murdoch Childrens Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia, Kirsten.perrett@rch.org.au.
Insights
A new vaccine, HibMenCY-TT, offers protection against Haemophilus influenzae type b (Hib) and meningococcal serogroups C and Y in infants. Clinical trials show it is safe, well-tolerated, and immunogenic for primary infant vaccination.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Immunology
Background:
- Meningococcal disease incidence is highest in infants under one year.
- Previously, no meningococcal vaccine was licensed for US infants.
- Serogroups C and Y are significant contributors to invasive meningococcal disease in the US.
Purpose of the Study:
- To review the novel HibMenCY-TT vaccine.
- To summarize clinical trial data for HibMenCY-TT.
- To describe recommended patient populations for HibMenCY-TT vaccination.
Main Methods:
- Review of a novel vaccine combining Haemophilus influenzae type b (Hib) and serogroups C and Y Neisseria meningitidis conjugated to tetanus toxoid.
- Summary of Phase II and III clinical trial data.
- Description of recommended infant vaccination schedules.
Main Results:
- HibMenCY-TT was found to be well tolerated, safe, and immunogenic in Phase II and III trials.
- The vaccine was administered at 2, 4, 6, and 12-15 months for primary vaccination.
- Antibodies against Hib and bactericidal activity against meningococcal serogroups C and Y were induced without increasing injection frequency.
Conclusions:
- HibMenCY-TT is a novel vaccine for infants providing protection against Hib and meningococcal serogroups C and Y.
- The vaccine is recommended for infants at increased risk of meningococcal disease.
- HibMenCY-TT can be administered concomitantly with routine infant vaccines and may benefit global vaccination programs.
Abstract:
The highest incidence of meningococcal disease occurs in infants younger than 1 year of age. However, in the US, prior to June 2012, there was no meningococcal vaccine licensed for use in this age group. In the US, where both serogroups C and Y contribute substantially to the overall epidemiology of invasive meningococcal disease, a vaccine combining these capsular polysaccharides was developed. We review the newly licensed HibMenCY-TT (MenHibrix™, GlaxoSmithKline Biologicals, Rixensart, Belgium), a novel vaccine containing Haemophilus influenzae type b (Hib) and serogroups C and Y Neisseria meningitidis conjugated to tetanus toxoid. We describe the vaccine, summarize the clinical trial data, and describe the patient populations recommended to receive HibMenCY-TT as their primary vaccination against Hib. Phase II and III clinical trials found HibMenCY-TT to be well tolerated, safe, and immunogenic when administered at 2, 4, 6, and 12-15 months of age for primary vaccination against both Hib and serogroups C and Y meningococcal disease. In October 2012, the Advisory Committee on Immunisation Practice in the US recommended HibMenCY-TT vaccination for infants at increased risk of meningococcal disease. HibMenCY-TT may be given concomitantly with other routine infant vaccines. It induces antibodies against Hib as well as bactericidal activity against meningococcal serogroup C and Y without increasing the number of injections required. As meningococcal disease epidemiology is dynamic, global surveillance remains essential. In the future, other countries may also benefit from the addition of HibMenCY-TT into their vaccine armamentarium against meningococcal disease.
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