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Trial record 1 of 1 for:    15694506 [PUBMED-IDS]
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Control of Epidemic Influenza Through a School-based Influenza Vaccination Program (CEI)

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ClinicalTrials.gov Identifier: NCT00138294
Recruitment Status : Completed
First Posted : August 30, 2005
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
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

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
Enrollment 29255
Recruitment Details 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  
Arm/Group Title Intervention Cities
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 29255
Completed 29255
Not Completed 0
Arm/Group Title Intervention Cities
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 29255
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29255 participants
<=18 years
29255
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 29255 participants
8
(5 to 17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29255 participants
Female
15106
  51.6%
Male
14149
  48.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29255 participants
Hispanic or Latino
9163
  31.3%
Not Hispanic or Latino
20092
  68.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29255 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29255 participants
29255
1.Primary Outcome
Title MAARI Rate During the Epidemic Period (2007-2008)
Hide Description The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.
Time Frame 12/16/2007 to 3/29/2008 (15 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.
Arm/Group Title Intervention Cities Comparison Cities
Hide Arm/Group Description:
Eligible children 4 years of age and older 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. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
Overall Number of Participants Analyzed 50665 67036
Overall Number of Units Analyzed
Type of Units Analyzed: Person Weeks
759975 1005540
Measure Type: Number
Unit of Measure: Number of MAARI
12503 18998
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Cities, Comparison Cities
Comments Overall Effectiveness against MAARI during the Epidemic Period (2007-2008)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.87 to 0.91
Estimation Comments [Not Specified]
2.Primary Outcome
Title MAARI Rate During the Epidemic Period (2008-2009)
Hide Description The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.
Time Frame 1/4/2009 to 3/21/2009 (11 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.
Arm/Group Title Intervention Cities Comparison Cities
Hide Arm/Group Description:
Eligible children 4 years of age and older 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. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
Overall Number of Participants Analyzed 50597 64969
Overall Number of Units Analyzed
Type of Units Analyzed: Person Weeks
556567 714659
Measure Type: Number
Unit of Measure: Number of MAARI
6630 12429
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Cities, Comparison Cities
Comments Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.67 to 0.71
Estimation Comments [Not Specified]
3.Primary Outcome
Title MAARI Rate During the Epidemic and Pandemic Period (2009-2010)
Hide Description The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.
Time Frame 8/25/09 to 4/3/10 (32 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.
Arm/Group Title Intervention Cities Comparison Cities
Hide Arm/Group Description:
Eligible children 4 years of age and older 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. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
Overall Number of Participants Analyzed 44610 56052
Overall Number of Units Analyzed
Type of Units Analyzed: Person Weeks
1427521 1793665
Measure Type: Number
Unit of Measure: Number of MAARI
15155 25984
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Cities, Comparison Cities
Comments Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.73 to 0.76
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Proportion of SAEs Detected in LAIV Recipients
Hide Description Serious adverse events (SAEs) within 42 days post-LAIV vaccination will be captured in seasonal and pandemic vaccinated study subjects.
Time Frame pre-, post- influenza vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analyses was limited to the children enrolled in the intervention cities. 29255 doses of LAIV were administered to children 4-18 years of age. 21555 doses were seasonal LAIV and 7700 doses were pandemic LAIV.
Arm/Group Title Influenza Vaccine
Hide Arm/Group Description:
Eligible children 4 years of age and older 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. Serious adverse events (SAEs) and MAARI adverse events within 42 days post-LAIV vaccination were captured in seasonal and pandemic LAIV vaccinated study subjects in the intervention area.
Overall Number of Participants Analyzed 29255
Measure Type: Number
Unit of Measure: proportion of events
Incidence of SAEs among seasonal LAIV recipients 0.00005
Incidence of SAEs among pandemic LAIV recipients 0.00012
Time Frame [Not Specified]
Adverse Event Reporting Description Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
 
Arm/Group Title All Enrolled Study Participants
Hide Arm/Group Description 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. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites will received their influenza vaccines (live attenuated or inactivated influenza vaccines) by the local healthcare providers
All-Cause Mortality
All Enrolled Study Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Enrolled Study Participants
Affected / at Risk (%)
Total   57/29255 (0.19%) 
Blood and lymphatic system disorders   
Sickle Cell Crisis   1/29255 (0.00%) 
Henoch-Schonlein Purpura   1/29255 (0.00%) 
Eye disorders   
Optic neuritis   1/29255 (0.00%) 
Gastrointestinal disorders   
Pharyngitis/Group A Strep/Abscess   1/29255 (0.00%) 
Gastroenteritis/Mesentric Adenitis   1/29255 (0.00%) 
Emesis and Weight Loss   1/29255 (0.00%) 
Appendicitis   10/29255 (0.03%) 
Acute abdominal pain   1/29255 (0.00%) 
Intussususception   1/29255 (0.00%) 
General disorders   
Sepsis   1/29255 (0.00%) 
Death   1/29255 (0.00%) 
Carbon Monoxide Poisoning   2/29255 (0.01%) 
Investigations   
Elective Surgery   5/29255 (0.02%) 
Musculoskeletal and connective tissue disorders   
Trauma/Skeletal Pain   2/29255 (0.01%) 
Soft tissue and/or bone infection   2/29255 (0.01%) 
Oilgoarticular post-infectious arthritis   1/29255 (0.00%) 
Nervous system disorders   
Migraine/Headache   1/29255 (0.00%) 
Seizure   2/29255 (0.01%) 
Meningitis   2/29255 (0.01%) 
Guillain Barre Syndrom   1/29255 (0.00%) 
Psychiatric disorders   
Psychiatric Disorder   3/29255 (0.01%) 
Renal and urinary disorders   
Urinary Tract Infection   1/29255 (0.00%) 
Respiratory, thoracic and mediastinal disorders   
Lower Respiratory Tract Infection (LRTI)   7/29255 (0.02%) 
2009 H1N1 Pneumonia/LRTI   6/29255 (0.02%) 
Acute Asthma Attack   2/29255 (0.01%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Enrolled Study Participants
Affected / at Risk (%)
Total   1/29255 (0.00%) 
Pregnancy, puerperium and perinatal conditions   
Pregnancy   1/29255 (0.00%) 
Indicates events were collected by systematic assessment
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
Publications of Results:
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