Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)
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|ClinicalTrials.gov Identifier: NCT00240877|
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 20, 2008
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: AV024 Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||August 2003|
|Actual Study Completion Date :||April 2004|
Monovalent vaccine prior to the release of the trivalent vaccine (FluMist).
0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
Placebo Comparator: 2
Placebo mist consisting of normal allantoic fluid. 0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
- - The primary endpoint of this study is fever defined as oral temperature ≥101°F [ Time Frame: Days 0-7 ]
- All other reported reactogenicity events and other adverse events. [ Time Frame: After 7 days after vaccination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240877
|United States, Florida|
|SFBC International Inc|
|Miami, Florida, United States, 33181|
|Study Director:||Robert Walker, MD||MedImmune LLC|