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Control of Epidemic Influenza Through a School-based Influenza Vaccination Program (CEI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00138294
First Posted: August 30, 2005
Last Update Posted: May 19, 2017
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.
Collaborators:
Scott and White Hospital & Clinic
Novartis
Sanofi Pasteur, a Sanofi Company
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Pedro Piedra, Baylor College of Medicine
Results First Submitted: February 1, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: live attenuated and inactivated influenza vaccines

  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 participants in the intervention cities were enrolled to the study and signed informed consent. The participants in the comparison cities were not enrolled to the study and the relevant data for these participants were obtained from the Scott and White Clinic database.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention Cities Eligible children 4 years of age and older whose parents provided consent (assent for children>7 years) in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.

Participant Flow:   Overall Study
    Intervention Cities
STARTED   29255 
COMPLETED   29255 
NOT COMPLETED   0 



  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
Intervention Cities Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.

Baseline Measures
   Intervention Cities 
Overall Participants Analyzed 
[Units: Participants]
 29255 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      29255 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 8 
 (5 to 17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15106  51.6% 
Male      14149  48.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      9163  31.3% 
Not Hispanic or Latino      20092  68.7% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      203   0.7% 
Asian      519   1.8% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2335   8.0% 
White      24699  84.4% 
More than one race      1499   5.1% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   29255 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   MAARI Rate During the Epidemic Period (2007-2008)   [ Time Frame: 12/16/2007 to 3/29/2008 (15 weeks) ]

2.  Primary:   MAARI Rate During the Epidemic Period (2008-2009)   [ Time Frame: 1/4/2009 to 3/21/2009 (11 weeks) ]

3.  Primary:   MAARI Rate During the Epidemic and Pandemic Period (2009-2010)   [ Time Frame: 8/25/09 to 4/3/10 (32 weeks) ]

4.  Secondary:   Proportion of SAEs Detected in LAIV Recipients   [ Time Frame: pre-, post- influenza 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: Pedro A Piedra, MD
Organization: Baylor College of Medicine
phone: 713-798-5240
e-mail: ppiedra@bcm.edu


Publications of Results:

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

Responsible Party: Pedro Piedra, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00138294     History of Changes
Other Study ID Numbers: BCM H-21853
Flu-035-09 ( Other Identifier: MedImmune Inc )
BCM H-21853 ( Other Identifier: Baylor College of Medicine )
SW070912 ( Other Identifier: Scott and White )
R01AI041050 ( U.S. NIH Grant/Contract )
First Submitted: August 26, 2005
First Posted: August 30, 2005
Results First Submitted: February 1, 2016
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017