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A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01427309
First received: August 30, 2011
Last updated: March 30, 2015
Last verified: March 2015
Results First Received: July 8, 2014  
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: High Dose Trivalent Inactivated Influenza Vaccine
Biological: Trivalent Inactivated Influenza 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 06 September through 09 October 2011 for Year 1; and 09 through 21 October 2012 for Year 2 at 126 sites in the United States and Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 31,989 participants were enrolled 31,983 were randomized and vaccinated in this study.

Reporting Groups
  Description
Fluzone® High Dose Vaccine (Year 1) Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
Fluzone® Vaccine (Year 1) Adults ≥65 years of age received one dose of Fluzone vaccine
Fluzone® High Dose Vaccine (Year 2) Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
Fluzone® Vaccine (Year 2) Adults ≥65 years of age received one dose of Fluzone vaccine

Participant Flow:   Overall Study
    Fluzone® High Dose Vaccine (Year 1)   Fluzone® Vaccine (Year 1)   Fluzone® High Dose Vaccine (Year 2)   Fluzone® Vaccine (Year 2)
STARTED   7253   7244   8737   8749 
COMPLETED   6881   6837   8376   8373 
NOT COMPLETED   372   407   361   376 
Lost to Follow-up                130                145                122                135 
Protocol Violation                42                69                125                124 
Adverse Event                0                0                3                1 
Serious adverse event                52                45                50                61 
Withdrawal by Subject                148                148                61                55 



  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.
The Full Analysis Set (FAS) as randomized, groups the participants according to the vaccine they were randomized to receive in the study.

Reporting Groups
  Description
Fluzone® High Dose Vaccine (Year 1) Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
Fluzone® Vaccine (Year 1) Adults ≥65 years of age received one dose of Fluzone vaccine
Fluzone® High Dose Vaccine (Year 2) Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
Fluzone® Vaccine (Year 2) Adults ≥65 years of age received one dose of Fluzone vaccine
Total Total of all reporting groups

Baseline Measures
   Fluzone® High Dose Vaccine (Year 1)   Fluzone® Vaccine (Year 1)   Fluzone® High Dose Vaccine (Year 2)   Fluzone® Vaccine (Year 2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 7253   7244   8737   8749   31983 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   0   0   0   0   0 
>=65 years   7253   7244   8737   8749   31983 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.3  (5.88)   73.2  (5.82)   73.3  (5.74)   73.4  (5.85)   73.3  (5.82) 
Gender 
[Units: Participants]
         
Female   4085   4041   5046   4922   18094 
Male   3168   3203   3691   3827   13889 
Region of Enrollment 
[Units: Participants]
         
United States   6953   6944   8315   8326   30538 
Canada   300   300   422   423   1445 


  Outcome Measures
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1.  Primary:   Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness (ILI).   [ Time Frame: ≥14 days post-vaccination ]

2.  Secondary:   Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Protocol-defined Influenza-like Illness (ILI)   [ Time Frame: ≥14 days post-vaccination ]

3.  Secondary:   Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness   [ Time Frame: ≥14 days post-vaccination ]

4.  Secondary:   Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Modified CDC-defined Influenza-like Illness.   [ Time Frame: ≥14 days post-vaccination ]

5.  Secondary:   Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Modified CDC-defined Influenza-like Illness   [ Time Frame: ≥14 days post-vaccination ]

6.  Secondary:   Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Respiratory Illness   [ Time Frame: ≥14 days post-vaccination ]

7.  Secondary:   Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Respiratory Illness   [ Time Frame: ≥14 days post-vaccination ]

8.  Other Pre-specified:   Safety Overview After Injection With Either Fluzone High Dose or Fluzone Vaccine Through the End of Surveillance Period   [ Time Frame: Day 0 up to Day 240 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 NOT 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.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01427309     History of Changes
Other Study ID Numbers: FIM12
U1111-1120-1300 ( Other Identifier: WHO )
Study First Received: August 30, 2011
Results First Received: July 8, 2014
Last Updated: March 30, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada