Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

1,359

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

August 31, 2006

Study Completion Date

August 31, 2006

Conditions
Influenza
Interventions
BIOLOGICAL

CSL Trivalent Inactivated Influenza Vaccine - Thimerosal-free

CSL influenza vaccine-prefilled syringe presentation (thimerosal-free) 15 mcg per dose of each of the hemagglutinins of H1N1, H3N2, and B strains (total of 45 mcg of hemagglutinins). Single dose of 0.5 mL administered on study day 0.

BIOLOGICAL

CSL Trivalent Inactivated Influenza Vaccine with Thimerosal

CSL influenza vaccine-multiple dose vial presentation (thimerosal-containing) containing 15 mcg per dose of each of the hemagglutinins of H1N1, H3N2, and B strains (total of 45 mcg of hemagglutinins). Single dose of 0.5 mL administered on study day 0.

BIOLOGICAL

Placebo with Thimerosal

Phosphate buffered isotonic saline solution containing thimerosal. Single dose of 0.5 mL administered on study day 0.

Trial Locations (10)

14642

University of Rochester, Rochester

21201

University of Maryland Baltimore, Baltimore

22003

Clinical Alliance for Research & Education - Infectious Diseases, Annandale

27704

Duke University Medical Center, Durham

52242

University of Iowa, Iowa City

63131

Saint Louis University, St Louis

77030

Baylor College of Medicine, Houston

94305-5208

Stanford University, Stanford

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

37232-2573

Vanderbilt University, Nashville

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00333398 - Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults | Biotech Hunter | Biotech Hunter