Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00390884
First received: October 20, 2006
Last updated: January 16, 2014
Last verified: January 2014
Results First Received: September 21, 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, Fluzone®

  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 into this study from 03 October 2006 to 04 January 2007 at 5 US clinical centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 173 participants were enrolled, vaccinated, and analyzed.

Reporting Groups
  Description
Fluzone®-Primed Group Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Fluzone®-Naive Group Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.

Participant Flow:   Overall Study
    Fluzone®-Primed Group     Fluzone®-Naive Group  
STARTED     116     57  
COMPLETED     114     55  
NOT COMPLETED     2     2  
Withdrawal by Subject                 2                 2  



  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®-Primed Group Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Fluzone®-Naive Group Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Total Total of all reporting groups

Baseline Measures
    Fluzone®-Primed Group     Fluzone®-Naive Group     Total  
Number of Participants  
[units: participants]
  116     57     173  
Age  
[units: participants]
     
<=18 years     116     57     173  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: Months]
Mean ± Standard Deviation
  13.8  ± 1.01     13.9  ± 1.13     13.8  ± 1.07  
Gender  
[units: participants]
     
Female     48     22     70  
Male     68     35     103  
Region of Enrollment  
[units: participants]
     
United States     116     57     173  



  Outcome Measures
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1.  Primary:   Percentage of Seroprotected Participants Post-vaccination With Fluzone®   [ Time Frame: Day 28 Post-vaccination ]

2.  Secondary:   Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®   [ Time Frame: Day 28 Post-vaccination ]

3.  Other Pre-specified:   Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®   [ Time Frame: Days 0-7 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: NCT00390884     History of Changes
Other Study ID Numbers: GRC29
Study First Received: October 20, 2006
Results First Received: September 21, 2009
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration