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Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)

NCT00694213 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-02-27

No results posted yet for this study

Summary

The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with the Biojector® 2000, and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system's response will be studied throughout the trial.

Conditions

Interventions

BIOLOGICAL

VCL-IPM1

IM, 0.5 mg/mL, 2 injections, 0 and 21 days

BIOLOGICAL

VCL-IPM1

IM, 1 mg/mL, 2 injections, 0 and 21 days

BIOLOGICAL

VCL-IPT1

IM, 1 mg/mL, 2 injections, 0 and 21 days

BIOLOGICAL

PBS

IM, 1 mL, 2 injections, 0 and 21 days

Sponsors & Collaborators

  • Vical

    lead INDUSTRY

Principal Investigators

  • Don Guterwill, BS, MT · Vical

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-09-30
Completion
2011-02-28

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 NCT00694213 on ClinicalTrials.gov