Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok

PHASE3CompletedINTERVENTIONAL
Enrollment

4,648

Participants

Timeline

Start Date

September 15, 2007

Primary Completion Date

May 28, 2008

Study Completion Date

May 28, 2008

Conditions
Influenza
Interventions
BIOLOGICAL

FluBlok®

Dose: 0.5 mL, single dose; Route of administration: intramuscular. Recombinant Trivalent Hemagglutinin Influenza Vaccine containing 45 microgram (mcg) of each hemagglutinin derived from A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004

BIOLOGICAL

Placebo

Dose: 0.5 mL normal saline for injection, single dose; Route of administration: intramuscular

Trial Locations (24)

13760

Regional Clinical Research, Inc., Endwell

14642

Rochester Medical Center, Rochester

15241

Primary Physicians Research - Pediatric Alliance St. Clair, Pittsburgh

Primary Physicians Research, Pittsburgh

21201

University of Maryland - Baltimore, Baltimore

22908

University of Virginia Health System, Charlottesville

27103

Carolina Medical Trials, Winston-Salem

33024

University Clinical Research, Inc, Pembroke Pines

37232

Vanderbilt University Medical Center, Nashville

40004

Kentucky pediatric /Adult Research, Bardstown

45246

Sterling Research, Cincinnati

54449

Marshfield Clinic, Marshfield

63110

Saint Louis University, St Louis

66212

Vince and Associates, Overland Park

68134

Meridian Clinical Research, Omaha

70006

Benchmarch Research - New Orleans, Metairie

76135

Benchmark Research - Fort Worth, Fort Worth

76904

Benchmark Research - San Angelo, San Angelo

77030

Baylor College of Medicine, Houston

78705

Benchmarch Research - Austin, Austin

84124

Jean Brown Research, Salt Lake City

90211

Impact Clinical Trials, Beverly Hills

94102

Benchmark Research - San Francisco, San Francisco

95816

Benchmark Research - Sacramento, Sacramento

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Protein Sciences Corporation

INDUSTRY

lead

Sanofi

INDUSTRY