Merino Arribas, Jose ManuelCarmona Martínez, AlfonsoHorn, MichaelPerez Porcuna, Xavier MariaOtero Reigada, Maria Del CarmenMarès Bermúdez, JosepCenteno Malfaz, FernandoMiranda, MarianoMendez, MariaGarcia Cabezas, Miguel AngelChristoph, WittermannBleckmann, GerhardFischbach, ThomasKolhe, DevayaniVan der Wielen, MarieBaine, Yaela2023-01-252023-01-252018http://hdl.handle.net/10668/12314This study evaluated the immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus virus-Haemophilus influenzae type b vaccine (DTPa-HBV-IPV/Hib) and a 10-valent pneumococcal conjugate vaccine (PHiD-CV) coadministered with a quadrivalent meningococcal conjugate vaccine (MenACWY-TT) in infants/toddlers. In this open, controlled, phase III study (NCT01144663), 2095 healthy infants were randomized (1:1:1:1) into 4 groups to receive 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 participants received PHiD-CV and DTPa-HBV-IPV/Hib at 2, 3, 4 and 12 months of age. Immunogenicity of DTPa-HBV-IPV/Hib was evaluated in exclusive randomized subsets of 25% of participants from each group postprimary, prebooster and postbooster vaccination, whereas immunogenicity of PHiD-CV was evaluated at all time points. Reactogenicity was evaluated on the total vaccinated cohorts during 8 days after each vaccination. For each DTPa-HBV-IPV/Hib antigen, ≥97.2%, ≥76.5% and ≥97.9% of participants had seropositive/seroprotective levels 1 month postprimary vaccination, before the booster dose and 1 month postbooster, respectively. For each vaccine pneumococcal serotype, ≥74.0% of infants had antibody concentrations ≥0.35 μg/mL at 1 month postprimary vaccination, and robust increases in antibody geometric mean concentrations were observed from prebooster to postbooster. Redness was the most frequent solicited local symptom at the DTPa-HBV-IPV/Hib and PHiD-CV injection sites, reported after up to 47.7% and 57.0% of doses postprimary and postbooster vaccination, respectively. Primary and booster vaccinations of infants/toddlers with DTPa-HBV-IPV/Hib and PHiD-CV coadministered with MenACWY-TT were immunogenic with clinically acceptable reactogenicity profiles. These results support the coadministration of MenACWY-TT with routine childhood vaccines.enAntibodies, BacterialAntibodies, ViralDiphtheria-Tetanus-Pertussis VaccineFemaleHaemophilus VaccinesHepatitis B VaccinesHumansImmunization ScheduleImmunization, SecondaryImmunogenicity, VaccineInfantMalePneumococcal VaccinesPoliovirus Vaccine, InactivatedVaccines, Combinedresearch article29620722open access10.1097/INF.00000000000020611532-0987http://links.lww.com/INF/D123