NCT00480155

A Study to Evaluate the Safety of a Monovalent Vaccine in Healthy Adults

A Prospective, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Safety of A Monovalent Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The objective is to assess the safety of a monovalent vaccine of a new 6:2 influenza virus reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist®) containing it.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Frozen FluMist®	Monovalent vaccine is supplied in intranasal sprayers containing 0.5 mL.
OTHER	Placebo

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-05-30
• Last updated: 2008-12-22

Locations

3 sites across 1 country: United States