Respiratory Syncytial Virus Infections Clinical Trial
Official title:
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 ΔNS2/Δ1313/I1314L or RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age
The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of the
recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L
or RSV 276 or placebo when delivered as nose drops to RSV-seronegative infants and children 6
to 24 months of age.
This study is a companion study to IMPAACT 2018.
Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower
respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study
will evaluate the infectivity, safety, and immunogenicity of two recombinant live-attenuated
RSV vaccines: RSV ΔNS2/Δ1313/I1314L and RSV 276. The vaccines will be delivered as nose drops
to RSV-seronegative infants and children 6 to 24 months of age.
Participants will be randomly assigned to receive a single dose of the RSV ΔNS2/Δ1313/I1314L
vaccine, the RSV 276 vaccine, or placebo at study entry (Day 0).
Participants will be enrolled in the study outside of RSV season, i.e., between April 1 and
October 31. All participants will remain on study until they complete the post-RSV season
visit between April 1 and April 30 in the calendar year following enrollment. Participants'
total study duration is between 6 and 13 months, depending on when they enroll in the study.
Participants will attend several study visits throughout the study, which may include
physical examinations, blood collection, nasal washes, and nasal adsorption (nasosorption)
specimen collection. Participants' parents or guardians will be contacted by study staff at
various times during the study to monitor participants' health.
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