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Safety, Tolerability and Immunogenicity of a Plant-Made H1 VLP Influenza Vaccine in Adults

NCT01302990 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-08-16

No results posted yet for this study

Summary

This is a Phase 1, randomized, double-blind, active- and placebo-controlled, multicenter, dose-ranging study to evaluate the safety, tolerability and Immunogenicity of a single non-adjuvanted dose of the H1 VLP Influenza vaccine in healthy adults 18-49 years of age.

Conditions

Interventions

BIOLOGICAL

Dose given at Day 0

Dose given by intramuscular administration (0.5 mL)

Sponsors & Collaborators

  • Medicago

    lead INDUSTRY

Principal Investigators

  • William E Gannon, MD · Accelovance

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-07-31
Completion
2011-11-30

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 NCT01302990 on ClinicalTrials.gov