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Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults

NCT01147068 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2012-11-26

Study results available
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Summary

The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations.

Conditions

Interventions

BIOLOGICAL

0.5mL Intramuscular Injection

0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle

Sponsors & Collaborators

  • Protein Sciences Corporation

    lead INDUSTRY

Principal Investigators

  • John Treanor, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

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 NCT01147068 on ClinicalTrials.gov