H5N1 Mix and Match With AS03

Status:	Archived
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
End Date:	May 2013

A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered at Different Dose Levels Given With and Without AS03 Adjuvant

Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years
old, inclusive, will be enrolled over a 2-month period into this multicenter, randomized,
double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study
and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted
vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular
subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg
given with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will
receive 2 doses separated by approximately 21 days.

This is a randomized, double-blinded, controlled, Phase I study in healthy male and
non-pregnant female subjects, 18 to 49 years old, inclusive, designed to assess the safety,
reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent
influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by sanofi pasteur
administered at different dosage levels (3.75, 7.5 or 15 mcg) given with the AS03 adjuvant
manufactured by GSK or PBS diluent.

We found this trial at

sites

Baylor School of Medicine

1 Baylor Plaza
Houston, Texas 77030

(713) 798-4951