A Study of Influenza Virus Vaccines in Children and Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00988143
First received: October 1, 2009
Last updated: November 18, 2013
Last verified: November 2013
Results First Received: July 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: 2009-2010 Trivalent Influenza Virus Vaccine
Biological: 2008-2009 Trivalent Influenza Virus Vaccine
Biological: Quadrivalent 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 01 October through 05 November 2009 in 4 clinical centers 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 600 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.

Reporting Groups
  Description
Study Group 1 (2009-2010 TIV) Participants received the 2009-2010 Trivalent Influenza Vaccine (Pediatric dose with no preservatives)
Study Group 2 (2008-2009 TIV) Participants received the 2008-2009 Trivalent Influenza Vaccine
Study Group 3 (QIV) Participants received the Quadrivalent Influenza Vaccine

Participant Flow:   Overall Study
    Study Group 1 (2009-2010 TIV)     Study Group 2 (2008-2009 TIV)     Study Group 3 (QIV)  
STARTED     220     190     190  
COMPLETED     220     190     190  
NOT COMPLETED     0     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
Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
Study Group 3 (Quadrivalent Influenza Vaccine) Participants received the Quadrivalent Influenza Vaccine (QIV)
Total Total of all reporting groups

Baseline Measures
    Study Group 1 (2009-2010 Trivalent Influenza Vaccine)     Study Group 2 (2008-2009 Trivalent Influenza Vaccine)     Study Group 3 (Quadrivalent Influenza Vaccine)     Total  
Number of Participants  
[units: participants]
  220     190     190     600  
Age  
[units: participants]
       
<=18 years     30     0     0     30  
Between 18 and 65 years     127     135     123     385  
>=65 years     63     55     67     185  
Age  
[units: Years]
Mean ± Standard Deviation
  47.8  ± 24.9     54.9  ± 17.5     56.7  ± 17.2     52.9  ± 20.8  
Gender  
[units: participants]
       
Female     144     124     130     398  
Male     76     66     60     202  
Region of Enrollment  
[units: Participants]
       
United States     220     190     190     600  



  Outcome Measures
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1.  Primary:   Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.   [ Time Frame: Day 0 up to 7 days post-vaccination ]

2.  Primary:   Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.   [ Time Frame: 21 Days post last vaccination ]

3.  Primary:   Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.   [ Time Frame: 21 Days post last vaccination ]

4.  Other Pre-specified:   Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 21 post final vaccination ]

5.  Other Pre-specified:   Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants   [ Time Frame: 21 Days post last vaccination ]

6.  Other Pre-specified:   Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines   [ Time Frame: Day 21 post-vaccination ]

7.  Other Pre-specified:   Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants   [ Time Frame: 21 Days post last vaccination ]

8.  Other Pre-specified:   Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines   [ Time Frame: Day 0 up to 21 days post-vaccination ]

9.  Other Pre-specified:   Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines   [ Time Frame: Day 0 (pre-vaccination) and Day 21 post final 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: NCT00988143     History of Changes
Other Study ID Numbers: GRC43, UTN: U1111-1111-5427
Study First Received: October 1, 2009
Results First Received: July 3, 2013
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration