We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00538512
First Posted: October 2, 2007
Last Update Posted: December 6, 2017
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.
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Arnold S. Monto, University of Michigan
Results First Submitted: August 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Fluzone
Biological: Flumist
Other: Physiologic saline

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[Units: Participants]
 814   813   325   1952 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      814 100.0%      813 100.0%      325 100.0%      1952 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      494  60.7%      519  63.8%      201  61.8%      1214  62.2% 
Male      320  39.3%      294  36.2%      124  38.2%      738  37.8% 
Region of Enrollment 
[Units: Participants]
       
United States   814   813   325   1952 


  Outcome Measures
  Show All 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: Time between prevaccination visit and postvaccination visit; typically about 30 days. ]

3.  Secondary:   Immune Response to Vaccination and Infection   [ Time Frame: Postvaccination to postseason visit; typically about 3 months. ]

4.  Secondary:   Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.   [ Time Frame: Time between prevaccination and postvaccination, typically about 30 days. ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

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 (0.00%)   0/813 (0.00%)   0/325 (0.00%) 



  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information