NCT00873912

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

A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a New 6:2 Influenza Virus Reassortant in Healthy Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This prospective annual release study was designed to assess the safety of a monovalent influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults received a single dose of vaccine or placebo and were followed for 180 days.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent influenza virus vaccine	Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 FFU (fluorescent focus units) of the cold-adapted, attenuated, 6:2 reassortant influenza strain B/Brisbane/60/2008 (Victoria lineage).
BIOLOGICAL	Placebo	Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer.

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-05-01
• Completion: 2009-12-01
• First posted: 2009-04-02
• Last updated: 2011-07-14
• Results posted: 2011-07-13

Locations

3 sites across 1 country: United States