Status:
COMPLETED
Inactivated Influenza A/H5N1 Vaccine in the Elderly
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research study is to compare how the body reacts to different strengths of a new H5N1 flu vaccine. Researchers will also look at how antibodies are made after subjects receive the ...
Detailed Description
The goals of this study are to compare the safety, reactogenicity, and immunogenicity of two dose levels of monovalent subvirion influenza A/H5N1 virus vaccine administered by injection to healthy eld...
Eligibility Criteria
Inclusion
- Ambulatory adult aged 65 and older.
- Is in good health, as determined by vital signs (heart rate \<100 bpm, blood pressure \[systolic less than or equal to 160 mm Hg and diastolic less than or equal to 90 mm Hg\] oral temperature \< 100 degrees F), medical history to ensure stable medical condition, and a targeted physical examination based on medical history.
- Able to understand and comply with planned study procedures.
- Provides informed consent prior to any study procedures and is available for all study visits.
Exclusion
- Has a known allergy to eggs or other components of the vaccine or sensitivity to latex.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder diagnosed or treated actively during the past 5 years.
- Is using oral or parenteral steroids, high-dose inhaled steroids (\>800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
- Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- Has a history of alcohol abuse or drug abuse (including chronic pain medication) in the last 5 years.
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long as there has been no dose adjustment within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).
- Has a history of severe reactions following immunization with influenza virus vaccines.
- Has an acute illness, including an oral temperature greater than 100.0 degrees F, within 1 week prior to vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 14-month study period.
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Has any diagnosis of dementia or associated concomitant medications (e.g., Aricept) used for treating dementia.
- Has known Latex allergy.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT00230750
Start Date
October 1 2005
End Date
January 1 2007
Last Update
August 23 2013
Active Locations (4)
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1
UCLA Center For Vaccine Research
Torrance, California, United States, 90502
2
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, United States, 14642-0001
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
4
Vanderbilt University
Nashville, Tennessee, United States, 37232-2573