NCT00240877

Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)

A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

To assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (FluMist).

Detailed description

The primary study objective is to assess the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist). Safety will be demonstrated by similar fever rates (oral temperature ≥101°F) in vaccine and placebo recipients.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	AV024	0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
OTHER	Placebo	Placebo mist consisting of normal allantoic fluid. 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).

Timeline

• Start date: 2002-08-01
• Primary completion: 2003-08-01
• Completion: 2004-04-01
• First posted: 2005-10-18
• Last updated: 2008-11-20

Locations

1 site across 1 country: United States