Status:
COMPLETED
Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)
Lead Sponsor:
MedImmune LLC
Conditions:
Influenza
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
To assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (FluMist).
Detailed Description
The primary study objective is to assess the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist). Safety will be demonstra...
Eligibility Criteria
Inclusion
- 18-64 years of age (not yet reached their 65th birthday);
- In good health;
- Available by telephone;
- Ability to understand and comply with the requirements of the protocol; and
- Signed informed consent.
Exclusion
- Any condition, other than age, for which the inactivated influenza vaccine is indicated, including: chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases (including diabetes mellitus) renal dysfunction, or hemoglobinopathies which required regular medical follow-up or hospitalization during the proceeding year;
- Acute febrile (\>100.0°F oral) illness or clinically significant respiratory illness within the 14 days prior to enrollment;
- Hypersensitivity to egg or egg protein;
- Signs or symptoms of any immunosuppressive or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household;
- Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study; and
- Any condition that in the opinion of the investigator, might interfere with the vaccine evaluation.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00240877
Start Date
August 1 2002
End Date
April 1 2004
Last Update
November 20 2008
Active Locations (1)
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1
SFBC International Inc
Miami, Florida, United States, 33181