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Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, D46/NS2/N/delta M2-2-HindIII, Lot RSV#011B, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

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IMPAACT 2013 is a double-blind, randomized, placebo-controlled trial that will evaluate the infectivity, safety, and immunogenicity of Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine D46/NS2/N/ΔM2-2-HindIII, Lot RSV#011B in infants and children confirmed to be RSV-seronegative within 42 days prior to inoculation. Approximately 33 healthy RSV-seronegative infants and children ≥6 months (180 days) to <25 months (750 days) of age will be enrolled. Eligible infants and children will receive a single dose of D46/NS2/N/ΔM2-2-HindIII vaccine or placebo intranasally at entry. Children 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.

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