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Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00389532
First received: October 18, 2006
Last updated: January 17, 2014
Last verified: January 2014
Results First Received: February 24, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Influenza Virus Vaccine (2006-2007 Fluzone® 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
Study participants were enrolled from October through December 2006 in 1 medical clinic 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 116 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
Aged 18 to 59 Years Participants aged 18 to 59 years at enrollment
Aged ≥ 60 Years Participants aged 60 years and older at enrollment

Participant Flow:   Overall Study
    Aged 18 to 59 Years     Aged ≥ 60 Years  
STARTED     60     56  
COMPLETED     60 [1]   56  
NOT COMPLETED     0     0  
[1] 3 of the participants did not have valid post-vaccination serological results



  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
Aged 18 to 59 Years Participants aged 18 to 59 years at enrollment
Aged ≥ 60 Years Participants aged 60 years and older at enrollment
Total Total of all reporting groups

Baseline Measures
    Aged 18 to 59 Years     Aged ≥ 60 Years     Total  
Number of Participants  
[units: participants]
  60     56     116  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     60     9     69  
>=65 years     0     47     47  
Age  
[units: years]
Mean ± Standard Deviation
  39.5  ± 12.25     76.4  ± 8.55     57.3  ± 21.33  
Gender  
[units: participants]
     
Female     49     37     86  
Male     11     19     30  
Region of Enrollment  
[units: participants]
     
United States     60     56     116  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination   [ Time Frame: 0-3 days post-vaccination ]

2.  Primary:   Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination   [ Time Frame: 21 days 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
Not Applicable.


  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: NCT00389532     History of Changes
Other Study ID Numbers: GRC35
Study First Received: October 18, 2006
Results First Received: February 24, 2009
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration