Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00561002
First received: November 19, 2007
Last updated: January 17, 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: 2007-2008 Influenza Virus 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
The study participants were enrolled from 29 October 2007 through 27 November 2007 at 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 34 participants who met the inclusion and exclusion criteria were enrolled, 2 were not vaccinated and excluded from the analysis.

Reporting Groups
  Description
Influenza Vaccine Naive/Inadequately Primed Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Influenza Vaccine Primed Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.

Participant Flow:   Overall Study
    Influenza Vaccine Naive/Inadequately Primed     Influenza Vaccine Primed  
STARTED     23     9  
COMPLETED     23     9  
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
Influenza Vaccine Naive/Inadequately Primed Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Influenza Vaccine Primed Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
Total Total of all reporting groups

Baseline Measures
    Influenza Vaccine Naive/Inadequately Primed     Influenza Vaccine Primed     Total  
Number of Participants  
[units: participants]
  23     9     32  
Age  
[units: participants]
     
<=18 years     23     9     32  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: Months]
Mean ± Standard Deviation
     
Age Continuous     19.8  ± 8.76     24.5  ± 5.10     21.2  ± 8.11  
Gender  
[units: participants]
     
Female     13     4     17  
Male     10     5     15  
Region of Enrollment  
[units: participants]
     
United States     23     9     32  



  Outcome Measures
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1.  Primary:   Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation   [ Time Frame: Days 0-3 post-dose ]

2.  Other Pre-specified:   Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination   [ Time Frame: Day 0 and Day 14 after last dose of Fluzone ]

3.  Other Pre-specified:   Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)   [ Time Frame: Day 14 post-vaccination ]

4.  Other Pre-specified:   Seroconversion Rates for Each Influenza Antigen Post-Vaccination   [ Time Frame: Day 14 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: NCT00561002     History of Changes
Other Study ID Numbers: GRC38
Study First Received: November 19, 2007
Results First Received: July 20, 2009
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration