Case Study

Early Engagement Crucial to Develop Trial Design for Accelerated Schedule Vaccine Study

Early Engagement Crucial to Develop Trial Design for Accelerated Schedule Vaccine Study

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CASE STUDY Early Engagement Crucial to Develop Trial Design for Accelerated Schedule Vaccine Study PRA’s Center for Vaccine Research’s Interpretation of Medical Informatics Data Key for Country Selection and Mitigation of Concomitant Vaccine ConstraintsRegions The initial study was conducted in Latin America (Panama). The expanded studies would have been conducted in Global Alliance for Vaccines and Immunization (GAVI) countries. STUDY DESCRIPTION A randomized, observer-blind, controlled, Phase I/II trial to evaluate the safety, tolerability, and immunogenicity of different doses of a standalone, trivalent inactivated poliomyelitis vaccine from Sabin strains in healthy infants. Prior to moving into the infant population of the study, safety and tolerability testing was com

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