C4801002 - A Phase 2, Randomized, Open-Label Trial to Describe the Safety and Immunogenicity of A Monovalent Pneumococcal Conjugate Candidate Administered As a 2-Dose Series in Healthy Toddlers 12 Through 15 Months of Age Who Previously Received PCV10 Primary Series in the European Union - C4801002

Pfizer Inc.0 个研究点目标入组 100 人开始时间: 2023年7月14日最近更新: 2024年7月22日

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试验速览

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•Toddlers =11 and =15 months of age at the time of consent., Have received exactly 2 infant doses of PCV10 according to a local immunization schedule., Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

•History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of study intervention, 13vPnC, 20vPnC, or any diphtheria toxoid–containing vaccine., Significant neurological disorder or history of seizure (excluding febrile seizure) or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders., Major known congenital malformation or serious chronic disorder., History of microbiologically proven invasive disease caused by S pneumoniae., Previous vaccination with any licensed pneumococcal vaccine (other than the PCV10 primary infant series) or investigational pneumococcal vaccine, or planned receipt of nonstudy pneumococcal vaccine during study participation.

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