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

PHASE4CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

May 31, 2009

Study Completion Date

December 31, 2009

Conditions
Healthy
Interventions
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.

Trial Locations (3)

32117

Covance CRU, Inc., Daytona Beach

78757

Covance CRU, Inc, Austin

97239

Covance CRU, Inc, Portland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY