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P1114 / Safety and Immunogenicity of an RSV Vaccine cps2

A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV cps2,
Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative
Infants and Children 6 to 24 Months of Age

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P1114 is a double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of the vaccine in seronegative infants and children. This protocol is a companion study to CIR 285, a study being conducted by the Center for Immunization Research (CIR, Johns Hopkins, Baltimore), and the Laboratory of Infectious Diseases (NIAID, Bethesda). The protocols have identical primary and secondary objectives; immunization schedules; evaluation assays and schedules; and safety monitoring and reporting. The protocols will vary slightly in site-selection requirements, eligibility requirements and site monitoring. These are all operational issues modified to account for the IMPAACT sites’ operations and infrastructure.

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