NCT00192127

Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This study is to assess the safety of a bivalent vaccine of two new 6:2 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them.

Detailed description

The primary study objective is to assess the safety of a bivalent vaccine of two new 6:2 influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist) containing them. Safety will be demonstrated by similar fever rates (oral temperature ≥101°F Days 0-7) in vaccine and placebo recipients.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	FluMist	A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0.
OTHER	Placebo	A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0

Timeline

• Start date: 2004-08-01
• Completion: 2005-02-01
• First posted: 2005-09-19
• Last updated: 2007-12-18

Locations

1 site across 1 country: United States