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

Eastern Equine Encephalitis Clinical Trial

Official title: A Multi-Site Phase 2 Open-Label, Safety and Immunogenicity Study of Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104 in Healthy Adults At Risk for Exposure to Eastern Equine Encephalitis Virus

Status Completed

Clinical Trial Summary

This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.

Clinical Trial Description

This was an open-label, vaccine study of Eastern Equine Encephalitis Vaccine, Inactivated Dried, EEE, TSI-GSD 104 in healthy, adult subjects. No concurrent control group was used. The controls used in this study to assess immunogenicity were historical PRNT80 values obtained in past studies of the EEE vaccine. Rates of adverse events (AEs) were tabulated by relationship to product administration and severity.

The primary objectives are to assess the safety of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104, and to assess immunogenicity of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104. ;

Related Conditions & MeSH terms

• Eastern Equine Encephalitis
• Encephalitis
• Encephalomyelitis, Equine

• NCT number: NCT00584805
• Study type: Interventional
• Source: U.S. Army Medical Research and Development Command
• Status: Completed
• Phase: Phase 2
• Start date: June 3, 2008
• Completion date: June 2017