Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: A pooled analysis of randomized trials

University of Louisville
Human Vaccines & Immunotherapeutics (Impact Factor: 2.37). 08/2012; 8(8). DOI: 10.4161/hv.20357
Source: PubMed


A pooled analysis was conducted of 1257 toddlers who received a fourth dose of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) or Hib conjugate vaccine (Hib polysaccharide conjugated to N. meningitidis outer membrane protein) coadministered with measles-mumps-rubella (MMR) and varicella (VAR) vaccines (NCT00134719/NCT00289783). Noninferiority of immunological responses to MMR and VAR was demonstrated between groups and incidences of MMR- and VAR-specific solicited symptoms were similar, indicating that HibMenCY-TT can be coadministered with MMR and VAR.

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Available from: Peter Richmond, Feb 17, 2014
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    • "Co-administration of HibMenCY-TT with DTPa-HBV-IPV and PVC7 at 2, 4, and 6 months did not cause immune interference to any concomitantly administered antigens [35]. Further, a pooled analysis of 1,257 toddlers found non inferiority of immune responses to measles, mumps and rubella, and varicella antigens when administered concomitantly with a fourth dose of HibMenCY-TT compared to Hib-OMP vaccine at 12–15 months of age [38]. "
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    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.
    Full-text · Article · Jun 2013
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    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.
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    ABSTRACT: CME EDUCATIONAL OBJECTIVES 1. Review the current epidemiology of meningococcal disease in children. 2. Discuss the history of meningococcal vaccine development and the unique challenges posed by developing a vaccine against this microbe. 3. Determine vaccine recommendations as well as potential roadblocks to routine vaccination of young children. The spectrum of disease caused by Neisseria meningitidis includes bacteremia, fulminant sepsis (meningococcemia), meningitis, and pneumonia. The incidence of meningococcal infection has long been higher in infancy than adolescents or adults older than 65 years (a third group with an increased risk based on age). Five meningococcal serogroups (A, B, C, Y, and W135) cause the great majority of human disease. Serogroup B strains cause about two-thirds of disease in children younger than 6 years. For this reason, new meningococcal vaccine formulations have been developed and evaluated in children younger than 2 years. Of four meningococcal vaccines currently licensed in the United States, two conjugate products, (MenACWY-D [Menactra], Sanofi Pasteur; HibMenCY-TT [MenHibrix], GlaxoSmithKline), are recommended for infants and toddlers younger than 2 years who have an increased risk for invasive meningococcal disease. High-risk conditions are complement deficiencies, community outbreaks, functional or anatomic asplenia, and travel to high-risk areas in which serogroup A infection is prevalent. Recommendations vary by age, dosing, and indication between these two products. Both licensed products are immunogenic and have side-effect profiles that are considered safe for use. In most cases, concomitant use with other recommended childhood vaccines does not interfere with responses to these vaccines. As of yet, there has not been universal adoption of this immunization in the infant population by parents or providers. Factors that weigh against the implementation of a national routine infant program include the prevention of only 40 to 50 meningococcal cases, two to four deaths per year, and a relatively low case fatality among infants. Some argue that costs should not be considered a barrier because infant deaths and morbidity would be prevented. The availability of a serogroup B vaccine would improve impact and cost-effectiveness of a routine infant meningococcal vaccine program. Debate over the implementation of routine infant meningococcal vaccination in the United States is ongoing. This review focuses on vaccines for the prevention of N. meningitidis infection in infants and young toddlers in the first 2 years of life.
    No preview · Article · Aug 2013 · Pediatric Annals
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