H5 Adult - Chiron Study of Bird Flu Vaccine

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

394

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

November 30, 2006

Study Completion Date

November 30, 2006

Conditions
Influenza
Interventions
BIOLOGICAL

Aluminum hydroxide

Provided in vials that contain 0.8 mL volume per vial.

BIOLOGICAL

Inactivated Influenza A/H5N1 Vaccine (Chiron)

Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg.

BIOLOGICAL

MF-59

Proprietary experimental adjuvant. Provided in vials that contain 0.7 mL volume per vial.

DRUG

Placebo

Saline placebo.

Trial Locations (4)

37232

Vanderbilt University, Nashville

63110

Saint Louis University, St Louis

94305-5208

Stanford University, Stanford

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00280033 - H5 Adult - Chiron Study of Bird Flu Vaccine | Biotech Hunter | Biotech Hunter