Immunogenicity and safety of 11- and 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccines (11vPHiD-CV, 12vPHiD-CV) in infants: Results from a phase II, randomised, multicentre study.

Alfonso Carmona Martinez,Roman Prymula,Mariano Miranda Valdivieso,Maria Del Carmen Otero Reigada, Jose Manuel Merino Arribas,Jerzy Brzostek,Leszek Szenborn,Renata Ruzkova,Michael R Horn,Teresa Jackowska,Fernando Centeno-Malfaz,Magali Traskine,Kurt Dobbelaere,Dorota Borys

Vaccine（2019）

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摘要

•11-/12-valent vaccines include 10 PHiD-CV conjugates + 19A(11v) + 6A(12v) CRM-conjugates.•11vPHiD-CV and 12vPHiD-CV were administered to infants according to a 3 + 1 schedule.•Immunogenicity was compared to PHiD-CV (common serotypes) and PCV13 (19A and 6A).•Post-dose 3 immune responses to investigational vaccines were non-inferior to comparators.•Safety and reactogenicity profiles of 11v/12vPHiD-CV were comparable to that of PHiD-CV.

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关键词

Pneumococcal conjugate vaccine,PHiD-CV,Immunogenicity,Non-inferiority,Safety,Infants/children

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