NCT00664417View on ClinicalTrials.gov

Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine

PHASE1CompletedINTERVENTIONAL
Enrollment

375

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

September 30, 2009

Study Completion Date

August 31, 2010

Conditions
InfluenzaOrthomyxoviridae Infections
Interventions
BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 1

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 2

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 3

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 4

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 5

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Formulation 6

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Comparator 1

BIOLOGICAL

Monovalent subvirion H5N1 influenza vaccine

0.5 mL, IM, 2 injections, Comparator 2

BIOLOGICAL

Physiological saline

0.5 mL, IM, 2 injections

Trial Locations (6)

33143

South Miami

37920

Knoxville

45219

Cincinnati

45227

Cincinnati

65802

Springfield

92103

San Diego

Sponsors

Lead Sponsor

Sanofi
All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT00664417 - Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine | Biotech Hunter | Biotech Hunter