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Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, To a Licensed Vaccine In Elderly Adults

NCT00395174 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 870

Last updated 2009-12-17

No results posted yet for this study

Summary

The purpose of this study were to obtain additional evidence in support of the safety and immunogenicity of a recombinant hemagglutinin (rHA) vaccine in an elderly population, and to establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a licensed trivalent influenza vaccine (TIV). Another purpose was to provide a preliminary estimate of the relative efficacy of the two vaccines against culture-positive influenza-like illness during the subsequent epidemic.

Conditions

Interventions

BIOLOGICAL

Influenza Vaccination

0.5mL dose for intramuscular injection

Sponsors & Collaborators

  • Protein Sciences Corporation

    lead INDUSTRY

Principal Investigators

  • Wendy A. Keitel, MD · Baylor College of Medicine

  • Hana M. El-Sahly, MD · Baylor College of Medicine

  • John J. Treanor, MD · University of Rochester Medical

  • Keith S. Reisinger, MD · Primary Physicians research

  • Gregory A. Poland, MD · Mayo Clinic College of Medicine

  • Kenneth D. Lessans, MD · Passport Health Maryland

  • John J. Minneti, MD · Passport Health New Jersey

  • Kristen Lyke, MD · Center of Vaccine Development, University of Maryland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-05-31
Completion
2007-05-31

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 NCT00395174 on ClinicalTrials.gov