Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01430819
First received: September 7, 2011
Last updated: May 16, 2013
Last verified: May 2013
Results First Received: March 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation

  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
Study participants were enrolled from 07 September through 24 October 2011 in 6 clinic sites 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 300 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
Fluzone® Vaccine Group Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
Fluzone® High-Dose Vaccine Group Participants received the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.

Participant Flow:   Overall Study
    Fluzone® Vaccine Group     Fluzone® High-Dose Vaccine Group  
STARTED     150     150  
COMPLETED     150     150  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Fluzone® Vaccine Group Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
Fluzone® High-Dose Vaccine Group Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
Total Total of all reporting groups

Baseline Measures
    Fluzone® Vaccine Group     Fluzone® High-Dose Vaccine Group     Total  
Number of Participants  
[units: participants]
  150     150     300  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     150     150     300  
Age  
[units: Months]
Mean ± Standard Deviation
  72.6  ± 5.8     71.6  ± 4.8     72.1  ± 5.3  
Gender  
[units: participants]
     
Female     91     92     183  
Male     59     58     117  
Region of Enrollment  
[units: Participants]
     
United States     150     150     300  



  Outcome Measures
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1.  Primary:   Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine   [ Time Frame: Day 0 to up to Day 28 post-vaccination ]

2.  Other Pre-specified:   Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.   [ Time Frame: Day 21 post-vaccination ]

3.  Other Pre-specified:   Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine   [ Time Frame: Day 21 post-vaccination ]

4.  Other Pre-specified:   Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.   [ Time Frame: Day 21 post-vaccination ]


  Serious Adverse Events


  Other Adverse Events


  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
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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.


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


No publications provided


Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01430819     History of Changes
Other Study ID Numbers: GRC48, U 1111-1120-1287
Study First Received: September 7, 2011
Results First Received: March 18, 2013
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration