IMPAACT 2018
Primary Protocol Team Members
Summary
IMPAACT 2018 is a double-blind, randomized, placebo-controlled trial that will evaluate the infectivity, safety, and immunogenicity of two recombinant live-attenuated respiratory syncytial virus vaccines (RSV ΔNS2/Δ1313/I1314L and RSV 276) in infants confirmed to be RSV-seronegative within 42 days prior to inoculation. Approximately 80 healthy RSV-seronegative infants ≥6 months (180 days) to <25 months (750 days) of age will be enrolled. Eligible infants will receive a single dose of RSV ΔNS2/Δ1313/I1314L or RSV 276 vaccine or placebo intranasally at entry. Participants will be enrolled in the protocol between April 1st and October 14th (outside of RSV season) and will remain on study until they complete the post-RSV season visit between April 1st and April 30th in the calendar year following enrollment.