We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00391391
First Posted: October 24, 2006
Last Update Posted: December 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
Results First Submitted: October 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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
ClinicalTrials.gov Identifier: NCT00391391     History of Changes
Other Study ID Numbers: FID07
First Submitted: October 23, 2006
First Posted: October 24, 2006
Results First Submitted: October 12, 2011
Results First Posted: November 22, 2011
Last Update Posted: December 1, 2011