Status:
COMPLETED
Trivalent rHA Dose Escalation Study in Elderly Subjects
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
65-80 years
Phase:
PHASE2
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...
Detailed Description
Approximately 400 healthy, ambulatory adults ages 65-80 will be randomized into one of four study groups to receive a single immunization of a licensed trivalent inactivated influenza vaccine or one o...
Eligibility Criteria
Inclusion
- Medically stable adult age 65 -80.
- Able to give informed consent.
- Able to comply with all study procedures.
- Community dwelling.
Exclusion
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT00170443
End Date
June 1 2004
Last Update
August 12 2011
Active Locations (3)
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1
University of Rochester
Rochester, New York, United States, 14642
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
Baylor College of Medicine
Houston, Texas, United States, 77030