Open Label Evaluation of H5N1 Vaccine at Vaccine Manufacturing Facilities

Completed · Phase 1/Phase 2

Conditions studied: Influenza

In brief

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 the vaccine. Up to 300 healthy people who are working at Aventis Pasteur H5N1 virus vaccine production facility in Swiftwater, PA, during the flu season are being asked to participate. It is important for vaccine production workers to receive the vaccine in order to minimize the risk of this bird flu virus combining with the regular flu virus. Volunteers in this study will have a medical screening, 2 vaccinations a month apart, 2 blood sample collections (1 before and 1 after the vaccinations to compare), 5 clinic visits, and follow-up over 6 months. They will also complete a diary card and to write down their temperature once a day and any symptoms they have every day during the week after they get their second shot. They will also be asked to write down any drugs or medicines they take.

Key facts

Study ID

NCT00311649

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

83

Starts

2005-11-01

Expected to finish

2006-09-01

Last updated by the study team

2011-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sanofi Pasteur — Swiftwater, Pennsylvania, United States

Full record on ClinicalTrials.gov

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