Perrett, Kirsten PHalperin, Scott ANolan, TerryCarmona Martínez, AlfonsoMartinón-Torres, FedericoGarcía-Sicilia, JoseVirta, MiiaVanderkooi, Otto GZuccotti, Gian VincenzoManzoni, PaoloKostanyan, LusineMeyer, NadiaCeregido, Maria AngelesCheuvart, BrigitteKuriyakose, Sherine OStranak, ZbynekMerino Arribas, Jose MCilleruelo Ortega, María JoséMiranda-Valdivieso, MarianoArias Novas, BegoñaRamos Amador, Jose TomasOmeñaca, FelixBaca, ManuelMarchisio, Paola GiovannaMesaros, Narcisa2023-02-082023-02-082019-11-24http://hdl.handle.net/10668/14752Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization. This phase IV, multi-country, open-label study assessed the immunogenicity and safety of infant primary vaccination with DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13). Enrolled infants (6-14 weeks old) were born to mothers who were randomized to receive reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) during pregnancy (270/7-366/7 weeks' gestation) with crossover immunization postpartum. All infants received 2 or 3 DTaP-HepB-IPV/Hib and PCV13 doses according to national schedules. Immunogenicity was assessed in infants pre- and 1 month post-primary vaccination. The primary objective was to assess seroprotection/vaccine response rates for DTaP-HepB-IPV/Hib antigens 1 month post-primary vaccination. 601 infants (Tdap group: 296; control group: 305) were vaccinated. One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups. Vaccine response rates for pertussis antigens were significantly lower in infants whose mothers received pregnancy Tdap (37.5-77.1%) versus placebo (90.0-99.2%). Solicited and unsolicited adverse event rates were similar between groups. Serious adverse events occurred in 2.4% (Tdap group) and 5.6% (control group) of infants, none were vaccination-related. Pertussis antibodies transferred during pregnancy may decrease the risk of pertussis infection in the first months of life but interfere with the infant's ability to produce pertussis antibodies, the clinical significance of which remains unknown. Safety and reactogenicity results were consistent with previous experience. ClinicalTrials.gov: NCT02422264.enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/BluntingInfantsMaternal immunizationPertussisTdap vaccineAntibodies, BacterialDiphtheria-Tetanus-Pertussis VaccineDiphtheria-Tetanus-acellular Pertussis VaccinesFemaleFollow-Up StudiesHaemophilus VaccinesHepatitis B VaccinesHumansInfantPneumococcal VaccinesPoliovirus Vaccine, InactivatedPregnancyVaccines, Combinedresearch article31776027open access10.1016/j.vaccine.2019.10.1041873-2518https://doi.org/10.1016/j.vaccine.2019.10.104