NCT00375206

Brief Summary

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 29, 2007

Status Verified

January 1, 2007

First QC Date

September 11, 2006

Last Update Submit

January 25, 2007

Conditions

Influenza

Keywords

PowderMed, DNA vaccine, influenza

Outcome Measures

Primary Outcomes (1)

  • Safety, tolerability and local reactogenicity - AEs and laboratory parameters

Secondary Outcomes (1)

  • Immunogenicity of the vaccine

Interventions

Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)BIOLOGICAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult volunteers (women must be of non child-bearing potential)
  • Provided written informed consent

You may not qualify if:

  • No significant concomitant illness
  • No allergy to gold
  • No immunosuppression due to disease or treatment
  • No previous flu vaccination in 2005 or 2006

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Quintiles Lenexa (QLX)

Lenexa, Kansas, 66219, United States

Location

Biokinetic

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Philip Leese, MD

    Quintiles, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 12, 2006

Study Start

September 1, 2006

Study Completion

January 1, 2007

Last Updated

January 29, 2007

Record last verified: 2007-01

Locations

US(2)