Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants 6 to 24 Months of Age

Summary

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.

Timeline

Start

2016-07-15

Primary completion

2017-07-07

Completion

2017-07-07

Outcome

Met primary endpoint

registry analysis (superiority test); RSV LID ΔM2-2 1030s Vaccine vs Placebo; p <0.01; Fisher Exact NCT02794870 ↗

registry analysis (superiority test); RSV LID ΔM2-2 1030s Vaccine vs Placebo; p <0.001; Log Rank NCT02794870 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RSV LID ΔM2-2 1030s	Vaccine	100000 unknown	Intranasal

Indications