NCT02654509

Safety and Immunogenicity Study of the Eastern Equine Encephalitis (EEE) Vaccine

Phase 2 Open-Label Safety and Immunogenicity Study of the Eastern Equine Encephalitis (EEE) Vaccine, Inactivated, Dried, TSI-GSD 104, Lot 2-1-89, in Healthy Adult Subjects at Risk of Exposure to Eastern Equine Encephalitis Virus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to collect safety and immunogenicity data for the Eastern Equine Encephalitis (EEE) vaccine.

Detailed description

This study is being conducted to collect safety and immunogenicity data for the Eastern Equine Encephalitis (EEE) vaccine. To determine the frequency of adverse events in this Eastern Equine Encephalitis (EEE) vaccine study for all intent-to-treat subjects will be evaluated. Also the frequency of clinically confirmed and documented cases of Eastern Equine Encephalitis (EEE) disease among vaccinated subjects compliant with titer schedule after working with Eastern Equine Encephalitis (EEE) virus.

Conditions

• Eastern Equine Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104	Eastern Equine Encephalitis Vaccine, Inactivated, Dried

Timeline

• Start date: 2008-06-03
• Primary completion: 2016-02-16
• Completion: 2018-03-18
• First posted: 2016-01-13
• Last updated: 2020-03-17

Locations

1 site across 1 country: United States