A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

PHASE4CompletedINTERVENTIONAL
Enrollment

303

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Influenza
Interventions
BIOLOGICAL

Trivalent Influenza Virus Vaccine

Trivalent vaccine is 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 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.

OTHER

Placebo

Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.

Trial Locations (3)

30281

Research Site, Stockbridge

33143

Research Site, Miami

97239

Research Site, Portland

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

MedImmune LLC

INDUSTRY