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Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00391391
First received: October 23, 2006
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
Results First Received: October 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Interventions: Biological: Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

  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
Study participants ere enrolled from 19 October to 12 December 2006 in 20 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 517 of the 520 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
Group 1: Fluzone ID at Age 6 to 35 Months Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
Group 2: Fluzone IM 6 to 35 Months Age Group Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
Group 3: Fluzone ID at 3 to 8 Years Age Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
Group 4: Fluzone IM 3 to 8 Years Age Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine

Participant Flow:   Overall Study
    Group 1: Fluzone ID at Age 6 to 35 Months     Group 2: Fluzone IM 6 to 35 Months Age Group     Group 3: Fluzone ID at 3 to 8 Years Age     Group 4: Fluzone IM 3 to 8 Years Age  
STARTED     98 [1]   97     161 [1]   164 [1]
COMPLETED     89     87     138     145  
NOT COMPLETED     9     10     23     19  
Adverse Event                 0                 0                 0                 1  
Lost to Follow-up                 1                 3                 7                 4  
Protocol Violation                 2                 3                 6                 7  
Withdrawal by Subject                 6                 4                 10                 7  
[1] 1 participant was not vaccinated.



  Baseline Characteristics
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Reporting Groups
  Description
Group 1: Fluzone ID at Age 6 to 35 Months Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
Group 2: Fluzone IM 6 to 35 Months Age Group Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
Group 3: Fluzone ID at 3 to 8 Years Age Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
Group 4: Fluzone IM 3 to 8 Years Age Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Total Total of all reporting groups

Baseline Measures
    Group 1: Fluzone ID at Age 6 to 35 Months     Group 2: Fluzone IM 6 to 35 Months Age Group     Group 3: Fluzone ID at 3 to 8 Years Age     Group 4: Fluzone IM 3 to 8 Years Age     Total  
Number of Participants  
[units: participants]
 		  97     97     160     163     517  
Age  
[units: participants]
 		         
<=18 years     97     97     160     163     517  
Between 18 and 65 years     0     0     0     0     0  
>=65 years     0     0     0     0     0  
Age  
[units: Months]
Mean ± Standard Deviation 		  22.6  ± 7.51     21.8  ± 8.03     69.6  ± 22.2     70.8  ± 21.6     46.5  ± 14.835  
Gender  
[units: participants]
 		         
Female     45     43     70     84     242  
Male     52     54     90     79     275  
Region of Enrollment  
[units: Participants]
 		         
United States     97     97     160     163     517  



  Outcome Measures
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1.  Primary:   Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine   [ Time Frame: Day 0 and Day 28 post-vaccination ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine   [ Time Frame: Day 28 post-vaccination ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine   [ Time Frame: Day 28 post-vaccination ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine   [ Time Frame: Day 28 post-vaccination ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.   [ Time Frame: Day 0 to Day 7 post-vaccination ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds   [ Time Frame: Day 0 to Day 7 post-vaccination ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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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.


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
ClinicalTrials.gov Identifier: NCT00391391     History of Changes
Other Study ID Numbers: FID07
Study First Received: October 23, 2006
Results First Received: October 12, 2011
Last Updated: November 21, 2011
Health Authority: United States: Food and Drug Administration