H5 Vaccine Alone or With Adjuvant in Healthy Adults

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

December 31, 2006

Study Completion Date

December 31, 2006

Conditions
Influenza
Interventions
DRUG

Aluminum hydroxide

Aluminum hydroxide adjuvant at 1200 mcg/mL.

BIOLOGICAL

Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)

Inactivated monovalent subvirion influenza H5N1 vaccine produced with and without Aluminum hydroxide adjuvant. All formulations of the H5N1 vaccine are supplied in a unit dose (0.5 mL) vial as a sterile solution for intramuscular injection. Vaccine with adjuvant is a turbid liquid whitish-grey in color. Vaccine without adjuvant is essentially clear and slightly opalescent in color.

Trial Locations (4)

14642

University of Rochester, Rochester

21201

University of Maryland Baltimore, Baltimore

27704

Duke University Medical Center, Durham

77030

Baylor College of Medicine, Houston

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00296634 - H5 Vaccine Alone or With Adjuvant in Healthy Adults | Biotech Hunter | Biotech Hunter