NCT00349037

Brief Summary

The purpose of this study is to evaluate how effective the vaccine is at preventing subjects developing flu symptoms after they are directly exposed to flu virus. The study will also evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 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

July 5, 2006

Last Update Submit

January 25, 2007

Conditions

Influenza

Keywords

DNA vaccineinfluenzaimmunogenicitytolerabilityPMEDefficacychallenge virus

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the vaccine in preventing symptoms of influenza-like illness

Secondary Outcomes (1)

  • Safety and tolerability - AEs and laboratory tests. Immunogenicity of the vaccine

Interventions

Trivalent DNA vaccine with and without pPJV2012 administered by PMEDBIOLOGICAL

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
  • Pre-existing protective level of antibody against the challenge virus strain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GDRU Quintiles Ltd

London, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Tim Mant, BSc, FRCP, FFPM

    GDRU

    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

July 5, 2006

First Posted

July 6, 2006

Study Start

September 1, 2006

Study Completion

January 1, 2007

Last Updated

January 29, 2007

Record last verified: 2007-01

Locations

GB(1)