Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

This study has been completed.
Sponsor:
Collaborator:
Sanofi Pasteur MSD
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00538512
First received: October 1, 2007
Last updated: August 8, 2011
Last verified: February 2009
Results First Received: August 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Fluzone
Biological: Flumist
Other: Physiologic saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fluzone - Trivalent Inactivated Influenza Vaccine the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
Flumist - Live-attenuated Influenza Vaccine live-attenuated influenza vaccine Flumist, manufactured by MedImmune
Placebo Physiologic saline administered as a nasal spray or intramuscular injection

Participant Flow:   Overall Study
    Fluzone - Trivalent Inactivated Influenza Vaccine     Flumist - Live-attenuated Influenza Vaccine     Placebo  
STARTED     814     813     325  
COMPLETED     787     783     312  
NOT COMPLETED     27     30     13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fluzone - Trivalent Inactivated Influenza Vaccine the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
Flumist - Live-attenuated Influenza Vaccine live-attenuated influenza vaccine Flumist, manufactured by MedImmune
Placebo Physiologic saline administered as a nasal spray or intramuscular injection
Total Total of all reporting groups

Baseline Measures
    Fluzone - Trivalent Inactivated Influenza Vaccine     Flumist - Live-attenuated Influenza Vaccine     Placebo     Total  
Number of Participants  
[units: participants]
  814     813     325     1952  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     814     813     325     1952  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  23.2  ± 7.4     23.5  ± 7.7     22.9  ± 6.7     23.3  ± 7.4  
Gender  
[units: participants]
       
Female     494     519     201     1214  
Male     320     294     124     738  
Region of Enrollment  
[units: participants]
       
United States     814     813     325     1952  



  Outcome Measures

1.  Primary:   Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza   [ Time Frame: one influenza season - 2007-2008 ]

2.  Secondary:   Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection   [ Time Frame: one influenza season - 2007-08 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
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Time Frame 6 months
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Fluzone - Trivalent Inactivated Influenza Vaccine the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
Flumist - Live-attenuated Influenza Vaccine live-attenuated influenza vaccine Flumist, manufactured by MedImmune
Placebo Physiologic saline administered as a nasal spray or intramuscular injection

Other Adverse Events
    Fluzone - Trivalent Inactivated Influenza Vaccine     Flumist - Live-attenuated Influenza Vaccine     Placebo  
Total, other (not including serious) adverse events        
# participants affected / at risk     0/814     0/813     0/325  



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information