drugset / Trial / NCT00936468

Safety, Tolerability and Immunogenicity of Fluzone® With and Without JVRS-100 in Elderly Subjects

NCT00936468

Phase 2 Completed 472 enrolled Colby Pharmaceutical Company
RandomizedParallel-groupTriple-blindPrevention

Summary

This study is designed to determine the optimal dose of JVRS-100 and assess safety, tolerability and immunogenicity of Fluzone® vaccine administered with JVRS-100 adjuvant at one of three dose levels compared to Fluzone® vaccine administered alone, in 472 adults aged ≥65 years.

Timeline

Start
2009-09
Primary completion
2010-06
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza Virus Vaccine Vaccine 45 ug Intramuscular
Subject JVRS-100 Unknown 3.75 ug Intramuscular
Subject JVRS-100 Unknown 7.5 ug Intramuscular
Subject JVRS-100 Unknown 25 ug Intramuscular

Indications