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Safety, Reactogenicity and Immunogenicity of an H5N1 VLP

NCT00519389 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2013-06-21

No results posted yet for this study

Summary

This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.

Conditions

  • Pandemic Influenza

Interventions

BIOLOGICAL

H5N1 VLP Vaccine

Two doses - Day 0 \& Day 28

BIOLOGICAL

Placebo

Two doses - Day 0 \& Day 28

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

  • George Atiee, M.D. · Healthcare Discoveries, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00519389 on ClinicalTrials.gov