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

PHASE4CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

July 31, 2008

Study Completion Date

December 31, 2008

Conditions
Influenza
Interventions
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.

Trial Locations (3)

32117

Covance, Daytona Beach, Daytona Beach

78752

Covance, Austin, Austin

97239

Covance, Portland, Portland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY

NCT00677820 - A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine | Biotech Hunter | Biotech Hunter