A Longitudinal Phase 2 Study for the Continued Evaluation of the Safety and Immunogenicity of a Live Francisella Tularensis Vaccine, NDBR 101, Lot 4

NCT00584844 Phase 2 COMPLETED Results posted

This study is designed to determine the safety and immunogenicity of a Live Francisella tularensis Vaccine

Details

Lead sponsor	U.S. Army Medical Research and Development Command
Phase	Phase 2
Status	COMPLETED
Enrolment	484
Start date	2004-10
Completion	2013-10

Conditions

• Tularemia

Interventions

• Live F tularensis Vaccine

Primary outcomes

• Safety: Adverse Event Category Rates for All Vaccinations — AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year
  AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule.

Countries

United States