BACKGROUND: Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02422264.

Alberta Children's Hospital University of Calgary Alberta Calgary Canada

Dalhousie University Canadian Center for Vaccinology Halifax Canada

GSK Bangalore India

GSK Wavre Belgium

Hospital Clínico San Carlos Madrid Spain

Hospital de Antequera Antequera Málaga Spain

Hospital La Zarzuela Aravaca Spain

Hospital Quiron Malaga Andalucia Malaga Spain

Hospital Universitario Madrid Sanchinarro Madrid Spain

Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Spain

Institute for the Care of Mother and Child Prague Czech Republic

Instituto Hispalense de Pediatría Sevilla Spain

Modis C O GSK Wavre Belgium

Murdoch Children's Research Institute and Melbourne School of Population and Global Health University of Melbourne Melbourne Australia

Neonatologia Hospital La Paz Madrid Spain

Nuevo Hospital Universitario de Burgos Burgos Spain

Ospedale dei Bambini Vittore Buzzi and University of Milan Milan Italy

Ospedale Ostetrico Ginecologico Sant'Anna Turin Italy and Department of Maternal Infant Pediatric Health Hospital Degli Infermi Biella Italy

Tampere Vaccine Research Center Tampere University Tampere Finland

Translational Pediatrics and Infectious Diseases Pediatrics Department Hospital Clínico Universitario de Santiago de Compostela and Genetics Vaccines and Pediatrics Research Group University of Santiago de Compostela Instituto de Investigación Sanitaria de Santiago de Compostela Santiago de Compostela Spain

Unità Pediatrica di Cure Altamente Intensive Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Lombardia Milano Italy

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ClinicalTrials.gov
NCT02422264