P1114 / Safety and Immunogenicity of an RSV Vaccine cps2
Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative
Infants and Children 6 to 24 Months of Age
Primary Protocol Team Members
Summary
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.