Respiratory Syncytial Virus Infections Clinical Trial
Official title:
Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID ΔM2-2 1030s, Lot RSV#010A, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age
The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a
single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in
RSV-seronegative infants 6 to 24 months of age.
This study was a companion study to CIR 311.
Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower
respiratory illness in infants and children under 5 years of age worldwide. This study
evaluated the safety, infectivity, and immunogenicity of a single dose of a recombinant
live-attenuated RSV vaccine, RSV LID ΔM2-2 1030s, in RSV-seronegative infants 6 to 24 months
of age.
Participants were randomly assigned to receive a single dose of the RSV LID ΔM2-2 1030s
vaccine or placebo (administered as nose drops) at study entry (Day 0).
Participants could be enrolled in the study between April 1 and October 14 (outside of RSV
season) and remained on study until they completed the post-RSV season visit between April 1
and April 30 in the calendar year following enrollment. Participants' total study duration
was between 6 to 10 months, depending on when they enrolled in the study. Participants
attended several study visits throughout the study, which included blood collection, nasal
washes, and/or physical examinations. Participants' parents or guardians were contacted by
study staff at various times during the study to monitor participants' health.
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