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

NCT00936468 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2011-02-14

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Fluzone® vaccine with JVRS-100 adjuvant or Fluzone alone

One vaccination on Day 0 of Fluzone® vaccine at 45ug mixed with one of three doses (3.75ug, 7.5ug, 25ug) of JVRS-100 adjuvant versus Fluzone® vaccine at 45ug alone.

Sponsors & Collaborators

  • Colby Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • Eric Sheldon, MD · Miami Research Associates, FL

  • Casey Johnson, DO · Johnson County Clin-Trials, KS

  • Stephan Sharp, MD · Clinical Research Associates, TN

  • Aurora Pop-Vicas, MD · Memorial Hospital, RI

  • James Borders, MD · Central Kentucky Research Associates, KY

  • Rex Biedenbender, MD · Eastern Virginia Medical School, VA

  • Derek Muse, M.D. · Jean Brown Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-06-30
Completion
2010-09-30

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Entities

Diseases

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 NCT00936468 on ClinicalTrials.gov