Continued Safety & Immunogenicity Study of a Live Francisella Tularensis

Clinical Trial Description

Study Objectives: 1. To assess the safety of live F. tularensis vaccine NDBR 101. 2. To assess the immunogenicity of live F. tularensis vaccine NDBR 101. ;

Study Design

Related Conditions & MeSH terms

Tularemia

See also
Status	Clinical Trial	Phase
Completed	`NCT00584844` - Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine	Phase 2
Recruiting	`NCT05300425` - Seroprevalence of Leptospirosis in Val Müstair, Switzerland
Withdrawn	`NCT03867162` - FY15-14: Tularemia Vaccine Protocol (NDBR Lot 4)	Phase 2

See also

Status

Clinical Trial

Phase

Completed

NCT00584844 - Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

Phase 2

Recruiting

NCT05300425 - Seroprevalence of Leptospirosis in Val Müstair, Switzerland

Withdrawn

NCT03867162 - FY15-14: Tularemia Vaccine Protocol (NDBR Lot 4)

Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT00787826
Study type	Interventional
Source	U.S. Army Medical Research and Development Command
Contact
Status	Enrolling by invitation
Phase	Phase 2
Start date	August 28, 2009
Completion date	December 1, 2021

Continued Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms