Dose-Escalating Trial Using Vero Cell-culture Derived H5N1 +/- Aluminum in Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

308

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

September 30, 2007

Study Completion Date

September 30, 2007

Conditions
Influenza
Interventions
BIOLOGICAL

Aluminum hydroxide

Adjuvant administered with A/H5N1 vaccine dosages 7.5 mcg and 15 mcg.

BIOLOGICAL

Inactivated Vero cell based whole virus influenza A/H5N1

Inactivated Vero cell-grown, whole virus, influenza A/H5N1 vaccine at dosages 7.5 mcg and 15 mcg of hemagglutinin (HA) per 0.5 mL, each dosage with and without aluminum hydroxide adjuvant; 45 mcg HA/0.5 mL without adjuvant.

DRUG

Placebo

Saline injected into the deltoid muscle. 2 identical dosages will be given approximately 28 days apart.

Trial Locations (5)

21201

University of Maryland School of Medicine, Baltimore

37232

Vanderbilt University, Nashville

77030

Baylor College of Medicine, Houston

90502

UCLA Center For Vaccine Research, Torrance

94305

Stanford University, Stanford

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00382980 - Dose-Escalating Trial Using Vero Cell-culture Derived H5N1 +/- Aluminum in Adults | Biotech Hunter | Biotech Hunter