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Safety and Efficacy Study of Fluzone® Vaccine Combined With Different Doses of JVRS-100 Adjuvant

NCT00662272 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2010-03-17

No results posted yet for this study

Summary

This study is designed to assess safety, tolerability and immunogenicity of Fluzone® vaccine with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy adults 18-49 years of age.

Conditions

Interventions

BIOLOGICAL

Fluzone vaccine with JVRS-100 adjuvant

One vaccination on Day 0 with Fluzone vaccine at 22.5µg mixed with JVRS-100 adjuvant at one of four dose levels (7.5µg, 25µg, 75µg, 225µg) given by IM injection in the upper deltoid.

BIOLOGICAL

Fluzone vaccine

One vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid.

BIOLOGICAL

Fluzone vaccine

One vaccination on Day 0 with Fluzone vaccine at 45µg given by IM injection in the upper deltoid.

Sponsors & Collaborators

  • Colby Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • Thomas P Monath, MD · Medical Monitor for Juvaris

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-10-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00662272 on ClinicalTrials.gov