Federico Martinón-Torres, Ignacio Salamanca de la Cueva, Michael Horn, Soeren Westerholt, Samantha Bosis, Nadia Meyer, Brigitte Cheuvart, Navpreet Virk, Rupert W Jakes, Maurine Duchenne, Peter Van den Steen
Since the introduction of Haemophilus Influenzae type b (Hib) conjugate vaccines, invasive Hib disease has strongly declined worldwide, yet continued control of Hib disease remains important. In Europe, currently three different hexavalent combination vaccines containing Hib conjugates are marketed. In this phase IV, single-blind, randomized, controlled, multi-country study (NCT04535037), we aimed to compare, in a 2 + 1 vaccination schedule, the immunogenicity and safety and show non-inferiority, as well as superiority, of DTPa-HBV-IPV/Hib (Ih group) versus DTaP5-HB-IPV-Hib (Va group) in terms of anti-polyribosylribitol phosphate (PRP) antibody geometric mean concentrations (GMCs) and proportion of participants reaching anti-PRP antibody concentrations greater than or equal to a threshold of 5 µg/mL...
December 31, 2024: Human Vaccines & Immunotherapeutics