Trivalent rHA Dose Escalation Study in Elderly Subjects
Completed · Phase 2
Conditions studied: Influenza
In brief
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.
Key facts
- Study ID
- NCT00170443
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 399
- Expected to finish
- 2004-06-01
- Last updated by the study team
- 2011-08-12
Who can join
Age: 65 and older, up to 80. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- University of Rochester — Rochester, New York, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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