Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT00138294
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2005-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Control of Epidemic Influenza Through a School-based Influenza Vaccination Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613429', 'term': 'FluMist'}, {'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ppiedra@bcm.edu', 'phone': '713-798-5240', 'title': 'Pedro A Piedra, MD', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).', 'eventGroups': [{'id': 'EG000', 'title': 'All Enrolled Study Participants', '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', 'otherNumAtRisk': 29255, 'otherNumAffected': 1, 'seriousNumAtRisk': 29255, 'seriousNumAffected': 57}], 'otherEvents': [{'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Psychiatric Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trauma/Skeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine/Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Soft tissue and/or bone infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis/Group A Strep/Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower Respiratory Tract Infection (LRTI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': '2009 H1N1 Pneumonia/LRTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Asthma Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sickle Cell Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis/Mesentric Adenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Emesis and Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intussususception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Henoch-Schonlein Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Guillain Barre Syndrom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oilgoarticular post-infectious arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Carbon Monoxide Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29255, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MAARI Rate During the Epidemic Period (2007-2008)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50665', 'groupId': 'OG000'}, {'value': '67036', 'groupId': 'OG001'}]}, {'units': 'Person Weeks', 'counts': [{'value': '759975', 'groupId': 'OG000'}, {'value': '1005540', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Cities', '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.'}, {'id': 'OG001', 'title': 'Comparison Cities', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '12503', 'groupId': 'OG000'}, {'value': '18998', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.87', 'ciUpperLimit': '0.91', 'groupDescription': 'Overall Effectiveness against MAARI during the Epidemic Period (2007-2008)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12/16/2007 to 3/29/2008 (15 weeks)', '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.', 'unitOfMeasure': 'Number of MAARI', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Person Weeks', 'denomUnitsSelected': 'Person Weeks', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'MAARI Rate During the Epidemic Period (2008-2009)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50597', 'groupId': 'OG000'}, {'value': '64969', 'groupId': 'OG001'}]}, {'units': 'Person Weeks', 'counts': [{'value': '556567', 'groupId': 'OG000'}, {'value': '714659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Cities', '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.'}, {'id': 'OG001', 'title': 'Comparison Cities', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '6630', 'groupId': 'OG000'}, {'value': '12429', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.71', 'groupDescription': 'Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '1/4/2009 to 3/21/2009 (11 weeks)', '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.', 'unitOfMeasure': 'Number of MAARI', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Person Weeks', 'denomUnitsSelected': 'Person Weeks', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'MAARI Rate During the Epidemic and Pandemic Period (2009-2010)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44610', 'groupId': 'OG000'}, {'value': '56052', 'groupId': 'OG001'}]}, {'units': 'Person Weeks', 'counts': [{'value': '1427521', 'groupId': 'OG000'}, {'value': '1793665', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Cities', '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.'}, {'id': 'OG001', 'title': 'Comparison Cities', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '15155', 'groupId': 'OG000'}, {'value': '25984', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.73', 'ciUpperLimit': '0.76', 'groupDescription': 'Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '8/25/09 to 4/3/10 (32 weeks)', '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.', 'unitOfMeasure': 'Number of MAARI', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Person Weeks', 'denomUnitsSelected': 'Person Weeks', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Proportion of SAEs Detected in LAIV Recipients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29255', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine', '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.'}], 'classes': [{'title': 'Incidence of SAEs among seasonal LAIV recipients', 'categories': [{'measurements': [{'value': '0.00005', 'groupId': 'OG000'}]}]}, {'title': 'Incidence of SAEs among pandemic LAIV recipients', 'categories': [{'measurements': [{'value': '0.00012', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'pre-, post- influenza vaccination', 'description': 'Serious adverse events (SAEs) within 42 days post-LAIV vaccination will be captured in seasonal and pandemic vaccinated study subjects.', 'unitOfMeasure': 'proportion of events', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Cities', '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29255'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29255'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29255', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Cities', '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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '29255', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15106', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14149', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9163', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20092', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '203', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '519', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2335', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '24699', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1499', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29255', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2005-08-26', 'resultsFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-16', 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MAARI Rate During the Epidemic Period (2007-2008)', 'timeFrame': '12/16/2007 to 3/29/2008 (15 weeks)', '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.'}, {'measure': 'MAARI Rate During the Epidemic Period (2008-2009)', 'timeFrame': '1/4/2009 to 3/21/2009 (11 weeks)', '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.'}, {'measure': 'MAARI Rate During the Epidemic and Pandemic Period (2009-2010)', 'timeFrame': '8/25/09 to 4/3/10 (32 weeks)', '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.'}], 'secondaryOutcomes': [{'measure': 'Proportion of SAEs Detected in LAIV Recipients', 'timeFrame': 'pre-, post- influenza vaccination', 'description': 'Serious adverse events (SAEs) within 42 days post-LAIV vaccination will be captured in seasonal and pandemic vaccinated study subjects.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['influenza vaccine', 'live attenuated influenza vaccine (LAIV or FluMist)', 'inactivated influenza vaccine (IIV)', 'School-based influenza vaccination program', 'children', 'herd protection'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '18401289', 'type': 'RESULT', 'citation': 'Gaglani MJ, Piedra PA, Riggs M, Herschler G, Fewlass C, Glezen WP. Safety of the intranasal, trivalent, live attenuated influenza vaccine (LAIV) in children with intermittent wheezing in an open-label field trial. Pediatr Infect Dis J. 2008 May;27(5):444-52. doi: 10.1097/INF.0b013e3181660c2e.'}, {'pmid': '17698577', 'type': 'RESULT', 'citation': 'Piedra PA, Gaglani MJ, Kozinetz CA, Herschler GB, Fewlass C, Harvey D, Zimmerman N, Glezen WP. Trivalent live attenuated intranasal influenza vaccine administered during the 2003-2004 influenza type A (H3N2) outbreak provided immediate, direct, and indirect protection in children. Pediatrics. 2007 Sep;120(3):e553-64. doi: 10.1542/peds.2006-2836. Epub 2007 Aug 13.'}, {'pmid': '17395338', 'type': 'RESULT', 'citation': 'Halloran ME, Piedra PA, Longini IM Jr, Gaglani MJ, Schmotzer B, Fewlass C, Herschler GB, Glezen WP. Efficacy of trivalent, cold-adapted, influenza virus vaccine against influenza A (Fujian), a drift variant, during 2003-2004. Vaccine. 2007 May 16;25(20):4038-45. doi: 10.1016/j.vaccine.2007.02.060. Epub 2007 Mar 12.'}, {'pmid': '16140685', 'type': 'RESULT', 'citation': 'Piedra PA, Gaglani MJ, Riggs M, Herschler G, Fewlass C, Watts M, Kozinetz C, Hessel C, Glezen WP. Live attenuated influenza vaccine, trivalent, is safe in healthy children 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age in a community-based, nonrandomized, open-label trial. Pediatrics. 2005 Sep;116(3):e397-407. doi: 10.1542/peds.2004-2258.'}, {'pmid': '15694506', 'type': 'RESULT', 'citation': 'Piedra PA, Gaglani MJ, Kozinetz CA, Herschler G, Riggs M, Griffith M, Fewlass C, Watts M, Hessel C, Cordova J, Glezen WP. Herd immunity in adults against influenza-related illnesses with use of the trivalent-live attenuated influenza vaccine (CAIV-T) in children. Vaccine. 2005 Feb 18;23(13):1540-8. doi: 10.1016/j.vaccine.2004.09.025.'}, {'pmid': '14706961', 'type': 'RESULT', 'citation': 'Gaglani MJ, Piedra PA, Herschler GB, Griffith ME, Kozinetz CA, Riggs MW, Fewlass C, Halloran ME, Longini IM Jr, Glezen WP. Direct and total effectiveness of the intranasal, live-attenuated, trivalent cold-adapted influenza virus vaccine against the 2000-2001 influenza A(H1N1) and B epidemic in healthy children. Arch Pediatr Adolesc Med. 2004 Jan;158(1):65-73. doi: 10.1001/archpedi.158.1.65.'}, {'pmid': '12915495', 'type': 'RESULT', 'citation': 'Halloran ME, Longini IM Jr, Gaglani MJ, Piedra PA, Chu H, Herschler GB, Glezen WP. Estimating efficacy of trivalent, cold-adapted, influenza virus vaccine (CAIV-T) against influenza A (H1N1) and B using surveillance cultures. Am J Epidemiol. 2003 Aug 15;158(4):305-11. doi: 10.1093/aje/kwg163.'}, {'pmid': '21028955', 'type': 'DERIVED', 'citation': 'Glezen WP, Gaglani MJ, Kozinetz CA, Piedra PA. Direct and indirect effectiveness of influenza vaccination delivered to children at school preceding an epidemic caused by 3 new influenza virus variants. J Infect Dis. 2010 Dec 1;202(11):1626-33. doi: 10.1086/657089. Epub 2010 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn if influenza vaccines (live attenuated and inactivated influenza vaccines), when given to school-aged children 4 to 18 years of age, can stop or lessen the influenza (flu) outbreak in the community. Another purpose is to show that vaccination of these children will significantly reduce breathing problems (in the vaccinated children and unvaccinated people they come in contact with in the community) that require a visit to the doctor for treatment. Another purpose is to continue to collect safety and flu protection information on live attenuated influenza vaccine (LAIV or FluMist) given to children. The study investigators believe that vaccination of healthy school-aged children is an effective plan for preventing many people in the community from catching the flu. Children will take part in the study for 5 to 10 months.', 'detailedDescription': 'This study was conducted in three phases. The first phase spanned from 1998-2003 (PubMed ID:14706961; PubMed ID: 12915495) and the second phase spanned from 2003-2007 (PubMedID: 18401289; PubMed ID: 17698577). The final phase of the study spanned 2007-2011 and is the scope of this submission.\n\nThe goal of the final phase is to control epidemic influenza through active immunization of healthy school-aged children with the cold-adapted, trivalent, live, attenuated influenza vaccine (LAIV) and at-risk children with the inactivated influenza vaccine (IIV) through a school-based vaccination program.\n\nThe hypothesis is that universal vaccination of healthy school-aged children is an alternative and effective strategy for the control of epidemic influenza, and will serve as a model for the control of pandemic influenza and biodefense. The specific aims of the study are: to control the spread of influenza to susceptible adults 35 years of age or older by vaccination of school-aged children 4-18 years of age; to control the spread of influenza to susceptible children and young adults less than 35 years of age by vaccination of school-aged children 4-18 years of age; to develop a school-based vaccination program for rapid and timely delivery of LAIV and IIV to children 4-18 years of age; to demonstrate in school-aged children the direct and total effectiveness of influenza vaccines to reduce the rates of medically attended acute respiratory illness (MAARI) in LAIV and IIV recipients during influenza epidemics; and to capture safety information on LAIV post-licensure.\n\nThis is an open-label, up to four year community-based study. In each of the first three study years, school-aged children (4 through 18 years of age) who receive medical care at the Scott \\& White Clinics (SWCs), Temple-Belton area, Texas, will be asked to participate in this study. Study participants will receive LAIV or IIV according to their health status. Other children from Temple-Belton area who do not receive medical care at the SWC will be invited to participate in the study and may receive LAIV or IIV. A comparable population enrolled in the SWCs in Waco/McLennan County area and Bryan/College Station will serve as comparison groups.\n\nIn the fourth and final year of the study, LAIV will not be provided through the study. However, influenza surveillance will continue and MAARI data will be collected to assess continued protective benefit of influenza vaccines. The final year will also be devoted to completion of data analysis and preparation of manuscripts.\n\nChildren 4 years through 8 years who have not previously been vaccinated with an influenza vaccine will be offered a second dose 4 to 6 weeks after the first dose. The influenza vaccines will contain the three influenza virus strains chosen by the FDA. Each subject will receive by nasal spray a 0.2 ml dose (0.1 ml in each nostril) of the LAIV or 0.5 ml intramuscularly.\n\nThe duration of each study year is approximately five to ten months, from the time of enrollment (August to January, at the discretion of the investigators) depending on vaccine availability and the timing of influenza activity, to the end of the influenza season (May).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent form by adult participant or parent/ legal guardian who are able to understand and comply with the protocol and assent when appropriate (usually age greater than or equal to 7 years)\n* healthy subject, 4 through 18 years of age and none of the exclusion criteria\n\nExclusion Criteria:\n\n* history of hypersensitivity, especially anaphylactic reaction, to any components of FluMist™, including eggs or egg products\n* on aspirin therapy or aspirin-containing therapy\n* history of Guillain-Barré syndrome\n* known or suspected immune deficiency diseases such as combined immunodeficiency, agammaglobulinemia, and thymic abnormalities and conditions such as human immunodeficiency virus infection, malignancy, leukemia or lymphoma\n* on immunosuppressive therapies such as systemic corticosteroids, alkylating drugs, antimetabolites, or radiation\n* close contact within 21 days after vaccination with immunocompromised individuals\n* history of asthma or reactive airway disease\n* history of chronic or underlying diseases for which the licensed inactivated flu vaccine (IIV-T) is recommended such as chronic disorders of the cardiovascular and pulmonary systems, or chronic conditions such as metabolic diseases, renal dysfunction or hemoglobinopathies that required medical follow-up or hospitalization during the preceding year\n* concurrent use with an anti-influenza compound\n* pregnant or plans to become pregnant within 42 days after vaccination\n* nursing mother and\n* any condition which, in the opinion of the investigator, interferes with evaluation of the vaccine'}, 'identificationModule': {'nctId': 'NCT00138294', 'acronym': 'CEI', 'briefTitle': 'Control of Epidemic Influenza Through a School-based Influenza Vaccination Program', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Phase 4, School-based, Open-labeled Research Trial for Control of Epidemic Influenza Through a School-based Influenza Vaccination Program in Central Texas.', 'orgStudyIdInfo': {'id': 'BCM H-21853'}, 'secondaryIdInfos': [{'id': 'Flu-035-09', 'type': 'OTHER', 'domain': 'MedImmune Inc'}, {'id': 'BCM H-21853', 'type': 'OTHER', 'domain': 'Baylor College of Medicine'}, {'id': 'SW070912', 'type': 'OTHER', 'domain': 'Scott and White'}, {'id': 'R01AI041050', 'link': 'https://reporter.nih.gov/quickSearch/R01AI041050', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Cities', '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.', 'interventionNames': ['Biological: live attenuated and inactivated influenza vaccines']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparison Cities', 'description': '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.', 'interventionNames': ['Biological: live attenuated and inactivated influenza vaccines']}], 'interventions': [{'name': 'live attenuated and inactivated influenza vaccines', 'type': 'BIOLOGICAL', 'otherNames': ['FluMist', 'Fluzone'], 'description': 'Live Attenuated Influenza Vaccine (LAIV) and Inactivated Influenza Vaccine (IIV) were administered to eligible children through a research program to improve vaccination coverage in school-aged children. Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) will be offered LAIV or IIV 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 received LAIV or IIV from the local healthcare providers', 'armGroupLabels': ['Comparison Cities', 'Intervention Cities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott & White Hospital and Clinic', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '76710', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott & White Hospital and Clinic', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}], 'overallOfficials': [{'name': 'Pedro A Piedra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scott and White Hospital & Clinic', 'class': 'OTHER'}, {'name': 'Novartis', 'class': 'INDUSTRY'}, {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pedro Piedra', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}