NCT00170443

Brief Summary

This study will compare the safety and immunogenicity of three different dose levels of an experimental recombinant influenza HA protein vaccine to a standard inactivated influenza vaccine in heallthy elderly subjects ages 65-80. Blood and nasal secretions for assessment of antibody responses will be obtained from all subjects prior to and one month after vaccination.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
399

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

August 12, 2011

Status Verified

April 1, 2006

First QC Date

September 9, 2005

Last Update Submit

August 11, 2011

Conditions

Influenza

Keywords

Influenza, Baculovirus, Immunogenicity, Geriatrics

Interventions

rHAO Trivalent Influenza VaccineBIOLOGICAL

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Medically stable adult age 65 -80.
  • Able to give informed consent.
  • Able to comply with all study procedures.
  • Community dwelling.

You may not qualify if:

  • History of immunodeficiency or treatment with immunosuppressive medications. (use of inhaled steroids or of topical steroids is not considered immunosuppressive).
  • Allergy to eggs, egg proteins, thimerosal, or other vaccine components.
  • Acute febrile illness or upper respiratory tract illness within 72 hours of vaccination.
  • Life expectancy less than 6 months.
  • Use of experimental vaccines or medications within one month of study entry.
  • Receipt of parenteral immunoglobulin within one month of study entry.
  • Any acute or chronic condition which in the opinion of the investigator would render vaccination unsafe or interfere with the evaluation of response.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Rochester

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Completion

June 1, 2004

Last Updated

August 12, 2011

Record last verified: 2006-04

Locations

US(3)