CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 128 enrolled
Drug / intervention
Fluzone vaccine with JVRS-100 adjuvant +2 morebiological
Likely dose
Fluzone vaccine with JVRS-100 adjuvant 22.5µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00662272
NCT00662272Phase 1Completed
CompareCT.gov

Randomized, Double Blind, Controlled Phase I Trial of the Safety, Tolerability and Immunogenicity of Fluzone® Inactivated Trivalent Influenza Virus Vaccine Administered With Ascending Doses of JVRS-100 Adjuvant

Colby Pharmaceutical Company·interventional·Posted Apr 21, 2008·Updated Mar 17, 2010

In Brief

A Phase 1 clinical trial evaluating Fluzone vaccine with JVRS-100 adjuvant and Fluzone vaccine for Influenza. Completed, enrolled 128 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 21, 2008
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2008
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.2 years ago

Interventions

Fluzone vaccine with JVRS-100 adjuvantbiological

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.

Fluzone vaccinebiological

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

Fluzone vaccinebiological

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