Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00831987
First received: January 28, 2009
Last updated: January 16, 2014
Last verified: January 2014
Results First Received: July 20, 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: Fluzone®: Influenza virus vaccine 2004-2005 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
The study participants were enrolled from 06 through 16 August 2004 in 1 US site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 120 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
Fluzone® Vaccine Group - Age 18-59 Years Participants received 1 dose of Fluzone® vaccine on Day 0.
Fluzone® Vaccine Group - Age ≥ 60 Years Participants received 1 dose of Fluzone® vaccine on Day 0.

Participant Flow:   Overall Study
    Fluzone® Vaccine Group - Age 18-59 Years     Fluzone® Vaccine Group - Age ≥ 60 Years  
STARTED     60     60  
COMPLETED     60     60  
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.
No text entered.

Reporting Groups
  Description
Fluzone® Vaccine Group - Age 18-59 Years Participants received 1 dose of Fluzone® vaccine on Day 0.
Fluzone® Vaccine Group - Age ≥ 60 Years Participants received 1 dose of Fluzone® vaccine on Day 0.
Total Total of all reporting groups

Baseline Measures
    Fluzone® Vaccine Group - Age 18-59 Years     Fluzone® Vaccine Group - Age ≥ 60 Years     Total  
Number of Participants  
[units: participants]
  60     60     120  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     60     4     64  
>=65 years     0     56     56  
Age  
[units: Years]
Mean ± Standard Deviation
  41.3  ± 11.1     74  ± 5.9     57.7  ± 18.7  
Gender  
[units: participants]
     
Female     44     38     82  
Male     16     22     38  
Region of Enrollment  
[units: participants]
     
United States     60     60     120  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination   [ Time Frame: 0 to 3 days post-vaccination ]

2.  Primary:   Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine   [ Time Frame: Day 0 and Day 21 Post-Vaccination ]

3.  Primary:   Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination   [ Time Frame: 21 Days post-vaccination ]

4.  Primary:   Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination   [ Time Frame: Day 21 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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00831987     History of Changes
Other Study ID Numbers: GRC20
Study First Received: January 28, 2009
Results First Received: July 20, 2009
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration