Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)
Completed · Phase 3 · Has a placebo group
Conditions studied: Influenza
In brief
To assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (FluMist).
Key facts
- Study ID
- NCT00240877
- Run by
- MedImmune LLC
- People needed
- 330
- Starts
- 2002-08-01
- Expected to finish
- 2004-04-01
- Last updated by the study team
- 2008-11-20
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- SFBC International Inc — Miami, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.