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Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00772109
First received: October 13, 2008
Last updated: April 12, 2016
Last verified: April 2016
Results First Received: July 16, 2011  
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
Conditions: Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B

  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 from 13 through 30 October 2008 in 50 clinics 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 4276 of the 4292 participants that met the inclusion and exclusion criteria enrolled were vaccinated.

Reporting Groups
  Description
Fluzone Intradermal (ID) Vaccine Lot 1 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
Fluzone Intradermal (ID) Vaccine Lot 2 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
Fluzone Intradermal (ID) Vaccine Lot 3 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
Fluzone Intramuscular (IM) Vaccine Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0

Participant Flow:   Overall Study
    Fluzone Intradermal (ID) Vaccine Lot 1   Fluzone Intradermal (ID) Vaccine Lot 2   Fluzone Intradermal (ID) Vaccine Lot 3   Fluzone Intramuscular (IM) Vaccine
STARTED   956   953   955   1428 
COMPLETED   935   934   936   1397 
NOT COMPLETED   21   19   19   31 
Serious adverse event                1                0                1                0 
Protocol Violation                5                8                7                6 
Lost to Follow-up                7                3                5                9 
Withdrawal by Subject                8                8                6                16 



  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
Fluzone Intradermal (ID) Vaccine Lot 1 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 1 on Day 0
Fluzone Intradermal (ID) Vaccine Lot 2 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 2 on Day 0
Fluzone Intradermal (ID) Vaccine Lot 3 Participants received a dose of Fluzone Intradermal (ID) vaccine Lot 3 on Day 0
Fluzone Intramuscular (IM) Vaccine Participants received a dose of Fluzone Intramuscular (IM) vaccine on Day 0
Total Total of all reporting groups

Baseline Measures
   Fluzone Intradermal (ID) Vaccine Lot 1   Fluzone Intradermal (ID) Vaccine Lot 2   Fluzone Intradermal (ID) Vaccine Lot 3   Fluzone Intramuscular (IM) Vaccine   Total 
Overall Participants Analyzed 
[Units: Participants]
 956   953   955   1428   4292 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   956   953   955   1428   4292 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.7  (13.41)   42.8  (13.33)   42.2  (13.78)   42.5  (13.55)   42.5  (13.5175) 
Gender 
[Units: Participants]
         
Female   611   619   594   899   2723 
Male   345   334   361   529   1569 
Region of Enrollment 
[Units: Participants]
         
United States   956   953   955   1428   4292 


  Outcome Measures
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1.  Primary:   Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines   [ Time Frame: Baseline (Day 0) and 28 Days post-vaccination ]

2.  Primary:   Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine   [ Time Frame: 28 Days post-vaccination ]

3.  Secondary:   Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM   [ Time Frame: Before and 28 Days post-vaccination ]

4.  Secondary:   Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine   [ Time Frame: Day 0 up to 7 Days 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



Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00772109     History of Changes
Other Study ID Numbers: FID31
Study First Received: October 13, 2008
Results First Received: July 16, 2011
Last Updated: April 12, 2016
Health Authority: United States: Food and Drug Administration