A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine

This prospective, randomized, double-blind, placebo-controlled release study enrolled 300 healthy adults 18 to 49 years of age. Eligible participants were randomly assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by intranasal spray. This study was conducted at multiple sites in the United States. Randomization was stratified by site. Each participant received one dose of investigational product on Day 1. The duration of study participation for each participant was the time from receipt of investigational product through 180 days after receipt of investigational product.