FLU-VACS Comparative Study in Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00133523|
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : December 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Cold-adapted live attenuated influenza virus vaccine, trivalent Other: Placebo Biological: Trivalent inactivated influenza vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2349 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparative Study of Influenza Vaccines in Adults - FLU-VACS|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
Placebo Comparator: Group 4: Placebo: Intramuscular
N=165 subjects administered placebo intramuscularly.
Physiological saline administered as an intramuscular injection.
Placebo Comparator: Group 3: Placebo: Nasal
N=165 subjects administered placebo intranasally.
Normal allantoic fluid administered annually as an internasal spray.
Experimental: Group 1: FluMist™
N=825 subjects administered live attenuated vaccine intranasally.
Biological: Cold-adapted live attenuated influenza virus vaccine, trivalent
Live-attenuated influenza vaccine; single annual dose administered as an intranasal spray.
Experimental: Group 2: Fluzone®/Fluvirin
N=825 subjects administered inactivated vaccine intramuscularly.
Biological: Trivalent inactivated influenza vaccine
Inactivated influenza vaccine; single annual dose administered as an intramuscular injection..Biological: Trivalent inactivated influenza vaccine
Inactivated influenza vaccine; single annual dose administered as an intramuscular injection.
- The appearance among patients of symptomatic laboratory-confirmed influenza. [ Time Frame: Influenza season Nov-Apr. Within 72 hours of illness onset throat swab specimens will be obtained from participants with influenza like illness (ILI). ]
- Any measurable increase in antibody titers, and the proportion with antibody levels considered protective. [ Time Frame: Annual enrollment, post vaccination Oct-Jan, and post season Apr-May. ]
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): NCT00133523
|United States, Michigan|
|Ann Arbor West|
|Ann Arbor, Michigan, United States, 48103|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109-2029|
|Western Michigan University Health Services|
|Kalamazoo, Michigan, United States, 49008|
|Livonia, Michigan, United States, 48150|
|Central Michigan University Health Services|
|Mt. Pleasant, Michigan, United States, 48859|
|Eastern Michigan University Health Services|
|Ypsilanti, Michigan, United States, 48197|