Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00388583
First received: October 16, 2006
Last updated: April 13, 2012
Last verified: April 2012
Results First Received: July 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Intervention: Biological: Split, Inactivated, Trivalent Influenza Vaccine

  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
Participants were enrolled from 28 September 2006 through 30 May 2007 in 16 clinics in the US

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 816 of the 817 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on the 807 participants that completed the study are presented.

Reporting Groups
  Description
Fluzone Intradermal (ID) Vaccine Group Participants received a dose of Fluzone Intradermal vaccine on Day 0
Fluzone Intramuscular (IM) Vaccine Group Participants received a dose of Fluzone Intramuscular vaccine on Day 0

Participant Flow:   Overall Study
    Fluzone Intradermal (ID) Vaccine Group     Fluzone Intramuscular (IM) Vaccine Group  
STARTED     407     410  
COMPLETED     401     406  
NOT COMPLETED     6     4  
Protocol Violation                 1                 0  
Withdrawal by Subject                 3                 3  
Serious Adverse Event                 2                 0  
Did not receive vaccine                 0                 1  



  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 ID Vaccine Group Participants received a dose (0.1 mL) of Fluzone intradermal vaccine on Day 0.
Fluzone IM Vaccine Group Participants received a dose (0.5 mL) of Fluzone intramuscular vaccine on Day 0.
Total Total of all reporting groups

Baseline Measures
    Fluzone ID Vaccine Group     Fluzone IM Vaccine Group     Total  
Number of Participants  
[units: participants]
  401     406     807  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     401     406     807  
Age  
[units: Years]
Mean ± Standard Deviation
  72.8  ± 6.08     72.3  ± 5.83     72.5  ± 5.955  
Gender  
[units: participants]
     
Female     234     223     457  
Male     167     183     350  
Region of Enrollment  
[units: Participants]
     
United States     401     406     807  



  Outcome Measures
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1.  Primary:   Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.   [ Time Frame: Pre-vaccination and Day 28 post-vaccination ]

2.  Primary:   Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.   [ Time Frame: Day 28 post-vaccination ]

3.  Secondary:   Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.   [ Time Frame: Pre- and Day 28 post-vaccination ]

4.  Secondary:   Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine   [ Time Frame: Day 0 up to 7 days post-vaccination ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com


No publications provided


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00388583     History of Changes
Other Study ID Numbers: FID04
Study First Received: October 16, 2006
Results First Received: July 14, 2011
Last Updated: April 13, 2012
Health Authority: United States: Food and Drug Administration