NCT00677820

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

A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Trivalent Vaccine of New 6:2 Influenza Virus Reassortants 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 trivalent influenza virus vaccine using a new strain recommended for the 2008-2009 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 was a prospective, randomized, double-blind, placebo-controlled release study. Eligible subjects were randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization was stratified by site. Each subject received 1 dose of study vaccine on Study Day 0. The duration of study participation for each subject was the time from study vaccination through 180 days after study vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent influenza virus vaccine	Trivalent 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 each of three cold-adapted, attenuated, 6:2 reassortant influenza strains A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006.
BIOLOGICAL	Placebo	Placebo was supplied in intranasal sprayers containing 0.5 ml of sucrose-phosphate buffer.

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-07-01
• Completion: 2008-12-01
• First posted: 2008-05-15
• Last updated: 2010-10-22
• Results posted: 2010-09-15

Locations

3 sites across 1 country: United States