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Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults

NCT00754455 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2013-07-18

No results posted yet for this study

Summary

A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in Healthy Adults.

Study Objectives:

Primary:

* To assess the tolerability and safety of Influenza VLP Vaccine
* To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the three component viral strains

Secondary:

* To evaluate the cross-strain immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers against drifted strains
* To quantify antibody against neuraminidase and hemagglutinin following administration of Influenza VLP Vaccine
* To assess cell-mediated immune (CMI) responses to Influenza VLP Vaccine as quantified by interferon-gamma (IFNg) and Granzyme-B produced by peripheral blood mononuclear cells (PBMCs).

Conditions

Interventions

BIOLOGICAL

Influenza VLP Vaccine (recombinant)

Single injection Day 0; 0.5mL

BIOLOGICAL

Placebo

Placebo as a single injection of 0.5 mL.

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

  • John E Ervin, M.D. · The Center for Pharmaceutical Research

  • Laurence Chu, M.D. · Benchmark Research

  • Larry Gilderman, D.O. · University Clinical Research

  • David L Freid, M.D. · Omega Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00754455 on ClinicalTrials.gov