Status:
COMPLETED
Open Label Evaluation of H5N1 Vaccine at Vaccine Manufacturing Facilities
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this research is to study side effects and safety of a new H5N1 flu (bird flu) vaccine and to look at how well people's immune systems make antibodies to fight infection after they get ...
Detailed Description
The primary goal of this phase I/II, single center, open label study is to obtain additional safety and immunogenicity data on two 90 µg doses of H5N1. It is anticipated that this dose level will resu...
Eligibility Criteria
Inclusion
- Working in the production of H5N1 vaccine at Aventis Pasteur facilities at Swiftwater, Pennsylvania.
- Male or nonpregnant female (as indicated by a negative urine pregnancy test prior to each dose of vaccine), aged 18 years and older.
- 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.
- Is in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, 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.
- Has a known allergy or sensitivity to latex (in the stopper).
- Is breastfeeding.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids, high-dose inhaled steroids (\>800 mcg/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 an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week of 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 6-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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00311649
Start Date
November 1 2005
End Date
September 1 2006
Last Update
August 12 2011
Active Locations (1)
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1
Sanofi Pasteur
Swiftwater, Pennsylvania, United States, 18370