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IMPAACT 2018

Randomized Phase I Study of the Infectivity, Safety, and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV delta NS2/delta 1313/I1314L or RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

Study Status

Participants Off Study and Primary Analysis Completed

DAIDS Number

38405

IND Number

17587

Clinical Trials Link

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.

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