Vaccination with meningococcal quadrivalent tetanus toxoid conjugate vaccine (MenACWY-TT) can be considered as an alternative option to using monovalent meningococcal vaccines in pediatric immunization schedules, and can be coadministered with the diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus virus-Haemophilus influenzae type b vaccine (DTPa-HBV-IPV/Hib) and 10-valent pneumococcal conjugate vaccine (PHiD-CV), according to new findings published in the Pediatric Infectious Disease Journal.
MenACWY-TT is licensed in Europe and was initially recommended for children aged 1 year and older. The indication was expanded to infants aged ≥6 weeks in 2016, based on clinical trial data. The current study is the first to evaluate the safety and immunogenicity of MenACWY-TT when coadministered with DTPa-HBV-IPV/Hib and PHiD-CV according to a 3+1 or 2+1 schedule in infants/toddlers.
The phase 3, randomized, multicenter trial (ClinicalTrials.gov identifier: NCT01144663) included 2095 infants aged 6 to 12 weeks who were assigned (1:1:1:1) into 4 groups: MenACWY-TT at 2, 3, 4, and 12 months of age or MenACWY-TT, MenC-CRM197, or MenC-TT at 2, 4, and 12 months of age. All the infants also received PHiD-CV and DTPa-HBV-IPV/Hib at 2, 3, 4, and 12 months of age.
After vaccination, a high percentage of the cohort achieved seroprotective antibody levels for anti-DT, anti-TT, anti-PRP, anti-HBs, and anti-poliovirus types 1, 2, and 3 antibodies for both postprimary (≥97.2%) and postbooster (≥97.9%) administration. For each of the pneumococcal serotypes included in the vaccine, ≥74.0% of infants had antibody concentrations ≥0.35 μg/mL at 1 month after primary vaccination, along with robust increases in antibody geometric mean concentrations from pre- to postbooster.
“This study showed that DTPa-HBV-IPV/Hib and PHiD-CV co-administered with MenACWY-TT in infants and toddlers were immunogenic with an acceptable reactogenicity profile,” the authors concluded.
Disclosure: GlaxoSmithKline Biologicals SA was the funding source and was involved in all stages of the study conduct and analysis.
Merino Arribas JM, Carmona Martínez A, Horn M, et al. Immunogenicity and reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV when co-administered with MenACWY-TT in infants: results of an open, randomized trial [published online March 31, 2018]. Pediatr Infect Dis J. doi: 10.1097/INF.0000000000002061