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

NCT00584805 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2019-09-24

Study results available
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Summary

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

Conditions

  • Eastern Equine Encephalitis

Interventions

BIOLOGICAL

Inactivated, Dried, TSI-GSD 104, EEE

Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Robert Rivard, MD · USAMRIID Medical Division

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-03
Primary Completion
2016-06-27
Completion
2017-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00584805 on ClinicalTrials.gov