Study of Quadrivalent Influenza Vaccine Among Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01240746
First received: November 11, 2010
Last updated: December 12, 2013
Last verified: December 2013
Results First Received: July 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative
Biological: Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative
Biological: Quadrivalent Influenza Vaccine, No Preservative

  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 11 November 2010 to 20 June 2011 in 69 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 4363 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 (2010-2011 Trivalent Influenza Vaccine) Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen.
Study Group 2 (Investigational Trivalent Influenza Vaccine) Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Study Group 3 (Investigational Quadrivalent Influenza Vaccine) Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)

Participant Flow:   Overall Study
    Study Group 1 (2010-2011 Trivalent Influenza Vaccine)     Study Group 2 (Investigational Trivalent Influenza Vaccine)     Study Group 3 (Investigational Quadrivalent Influenza Vaccine)  
STARTED     736     725     2902  
COMPLETED     677     677     2659  
NOT COMPLETED     59     48     243  
Adverse Event                 2                 0                 10  
Lost to Follow-up                 23                 20                 102  
Protocol Violation                 24                 15                 72  
Withdrawal by Subject                 10                 13                 59  



  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 (Trivalent Influenza Vaccine) Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Study Group 2 (Investigational Trivalent Influenza Vaccine) Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Study Group 3 (Investigational Quadrivalent Influenza Vaccine) Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Total Total of all reporting groups

Baseline Measures
    Study Group 1 (Trivalent Influenza Vaccine)     Study Group 2 (Investigational Trivalent Influenza Vaccine)     Study Group 3 (Investigational Quadrivalent Influenza Vaccine)     Total  
Number of Participants  
[units: participants]
  736     725     2902     4363  
Age  
[units: participants]
       
<=18 years     736     725     2902     4363  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: Months]
Mean ± Standard Deviation
  49.6  ± 29.0     49.6  ± 28.7     49.8  ± 29.7     49.8  ± 29.4  
Gender  
[units: participants]
       
Female     367     359     1427     2153  
Male     369     366     1475     2210  
Region of Enrollment  
[units: Participants]
       
United States     736     725     2902     4363  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants   [ Time Frame: Day 28 post final vaccination ]

2.  Primary:   Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants   [ Time Frame: Day 28 post final vaccination ]

3.  Primary:   Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants   [ Time Frame: Day 28 post final vaccination ]

4.  Primary:   Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.   [ Time Frame: Day 28 post final vaccination ]

5.  Primary:   Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.   [ Time Frame: Day 28 post-vaccination ]

6.  Other Pre-specified:   Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants   [ Time Frame: Day 28 post final vaccination ]

7.  Other Pre-specified:   Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants   [ Time Frame: Day 28 post final vaccination ]

8.  Other Pre-specified:   Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants   [ Time Frame: Day 28 post final vaccination ]

9.  Other Pre-specified:   Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants.   [ Time Frame: Day 28 post final vaccination ]

10.  Other Pre-specified:   Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.   [ Time Frame: Day 28 post final vaccination ]

11.  Other Pre-specified:   Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.   [ Time Frame: Day 28 post-vaccination ]

12.  Other Pre-specified:   Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants   [ Time Frame: Day 28 post-vaccination ]

13.  Other Pre-specified:   Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants   [ Time Frame: Day 28 post final vaccination ]

14.  Other Pre-specified:   Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines.   [ Time Frame: Day 0 up to Day 7 post-vaccination ]

15.  Other Pre-specified:   Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines   [ Time Frame: Day 0 up to Day 7 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: NCT01240746     History of Changes
Other Study ID Numbers: QIV04, UTN: U1111-1114-3713
Study First Received: November 11, 2010
Results First Received: July 3, 2013
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration