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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00311649 |
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Date of registration:
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05/04/2006 |
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Primary sponsor: |
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Public title:
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Open Label Evaluation of H5N1 Vaccine at Vaccine Manufacturing Facilities
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Scientific title:
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Open Label Evaluation of H5N1 Vaccine at Vaccine Manufacturing Facilities |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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83 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00311649 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Working in the production of H5N1 vaccine at Aventis Pasteur facilities at
Swiftwater, Pennsylvania.
2. Male or nonpregnant female (as indicated by a negative urine pregnancy test prior to
each dose of vaccine), aged 18 years and older.
3. 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.
4. 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.
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 Criteria:
1. Has a known allergy to eggs or other components of the vaccine.
2. Has a known allergy or sensitivity to latex (in the stopper).
3. Is breastfeeding.
4. Is undergoing immunosuppression as a result of an underlying illness or treatment.
5. Has an active neoplastic disease or a history of any hematologic malignancy.
6. Is using oral or parenteral steroids, high-dose inhaled steroids (>800 mcg/day of
beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic
drugs.
7. Has a history of receiving immunoglobulin or other blood product within the 3 months
prior to enrollment in this study.
8. Has an acute illness, including an oral temperature greater than 100.4 degrees F,
within 1 week of vaccination.
9. 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.
10. 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Influenza
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Intervention(s)
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Biological: Inactivated Influenza A Vaccine A/H5N1
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Secondary ID(s)
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05-0129
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Influenza CVD 16000
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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