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Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine

NCT01244867 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2012-07-31

No results posted yet for this study

Summary

The primary objective is to assess the immunogenicity and safety and tolerability of two consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®, compared to the placebo, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80).

Conditions

  • Virus Diseases
  • RNA Virus Infections
  • Respiratory Tract Diseases
  • Respiratory Tract Infections

Interventions

BIOLOGICAL

20 micrograms dose H5 VLP

2 doses given 21 days apart of 20 micrograms of H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

30 micrograms dose H5 VLP

2 doses given 21 days apart of 30 micrograms of H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

45 micrograms dose H5 VLP

2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

45 micrograms non-adjuvanted H5 VLP

2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine

BIOLOGICAL

Placebo

2 doses given 21 days apart of the placebo

Sponsors & Collaborators

Principal Investigators

  • Edward M. Sellers, MD · Kendle Early Stage Toronto Canada

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-07-31
Completion
2011-09-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

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 NCT01244867 on ClinicalTrials.gov