Status:
COMPLETED
A/H5N1in Adult - Aventis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research study is to compare how the body reacts to different strengths of the new H5N1 flu vaccine. The study will also look at how antibodies are made after a subject receives th...
Detailed Description
Approximately 450 healthy adults, 18 to 64 years old, inclusive, will be enrolled into this multicenter, randomized, double-blinded, placebo-controlled, dose-ranging clinical trial. The study will be ...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria to participate in this study: 1. Male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 64 years, inclusive. 2. Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (ie, barrier method, abstinence, and licensed hormonal methods) for the entire study period. 3. Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history. 4. In Stage I subjects, should have normal laboratory values of Hgb, WBC, Plt, ALT, and creatinine prior to the first immunization. 5. Able to understand and comply with planned study procedures. 6. Provides informed consent prior to any study procedures and is available for all study visits.
Exclusion
- Subjects who meet any of the following exclusion criteria at baseline will be excluded from study participation: 1. Has a known allergy to eggs or other components of the vaccine. 2. Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding. 3. Is undergoing immunosuppression as a result of an underlying illness or treatment. 4. Has an active neoplastic disease or a history of any hematologic malignancy. 5. Is using oral or parenteral steroids, high-dose inhaled steroids (\>800 µg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs. 6. Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study. 7. Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study. 8. 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 (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients). 9. Has a history of severe reactions following immunization with contemporary influenza virus vaccines. 10. Has an acute illness, including an oral temperature greater than 100.4ºF, within 1 week of vaccination. 11. 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 7-month study period. 12. 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT00115986
Start Date
March 1 2005
End Date
February 1 2006
Last Update
August 23 2013
Active Locations (3)
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1
UCLA Center For Vaccine Research
Torrance, California, United States, 90502
2
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
3
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, United States, 14642-0001