Safety and Efficacy Study of Fluzone® Vaccine Combined With Different Doses of JVRS-100 Adjuvant

PHASE1CompletedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

October 31, 2008

Study Completion Date

December 31, 2009

Conditions
Influenza
Interventions
BIOLOGICAL

Fluzone vaccine with JVRS-100 adjuvant

One vaccination on Day 0 with Fluzone vaccine at 22.5µg mixed with JVRS-100 adjuvant at one of four dose levels (7.5µg, 25µg, 75µg, 225µg) given by IM injection in the upper deltoid.

BIOLOGICAL

Fluzone vaccine

One vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid.

BIOLOGICAL

Fluzone vaccine

One vaccination on Day 0 with Fluzone vaccine at 45µg given by IM injection in the upper deltoid.

Trial Locations (2)

33143

Miami Research Associates, Miami

66219

Johnson County Clin-Trials, Lenexa

Sponsors
All Listed Sponsors
lead

Colby Pharmaceutical Company

INDUSTRY