Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-23 @ 5:05 AM
Study NCT ID:
NCT01997450
Status:
TERMINATED
Last Update Posted:
2025-03-10
First Post:
2013-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'A nasal swab specimen will be collected and tested for influenza and other viral pathogens.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4121}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'FDA did not require the fourth season of recruitment as planned originally. Study closed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2016-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2013-11-22', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of cases positive for wild-type influenza with an end-point PCR genotyping assay.', 'timeFrame': 'Up to 6 months for each individual flu season', 'description': 'Vaccine Effectiveness is defined as 100 x (1-odds ratio), where the odds ratio is the odds of exposures (Q/LAIV versus Inactivated Influenza Vaccine or no vaccine) among laboratory confirmed cases of flu versus controls. Effectiveness will be monitored by flu season, class of age and by influenza strain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Q/LAIV/FluMist® Quadrivalent Vaccine', 'Inactivated Influenza Vaccine (IIV)', 'Effectiveness', 'Influenza'], 'conditions': ['Influenza Vaccine Effectiveness']}, 'referencesModule': {'references': [{'pmid': '29029064', 'type': 'DERIVED', 'citation': 'Poehling KA, Caspard H, Peters TR, Belongia EA, Congeni B, Gaglani M, Griffin MR, Irving SA, Kavathekar PK, McLean HQ, Naleway AL, Ryan K, Talbot HK, Ambrose CS. 2015-2016 Vaccine Effectiveness of Live Attenuated and Inactivated Influenza Vaccines in Children in the United States. Clin Infect Dis. 2018 Feb 10;66(5):665-672. doi: 10.1093/cid/cix869.'}, {'pmid': '28408121', 'type': 'DERIVED', 'citation': 'McLean HQ, Caspard H, Griffin MR, Poehling KA, Gaglani M, Belongia EA, Talbot HK, Peters TR, Murthy K, Ambrose CS. Effectiveness of live attenuated influenza vaccine and inactivated influenza vaccine in children during the 2014-2015 season. Vaccine. 2017 May 9;35(20):2685-2693. doi: 10.1016/j.vaccine.2017.03.085. Epub 2017 Apr 10.'}, {'pmid': '27613072', 'type': 'DERIVED', 'citation': 'Caspard H, Coelingh KL, Mallory RM, Ambrose CS. Association of vaccine handling conditions with effectiveness of live attenuated influenza vaccine against H1N1pdm09 viruses in the United States. Vaccine. 2016 Sep 30;34(42):5066-5072. doi: 10.1016/j.vaccine.2016.08.079. Epub 2016 Sep 6.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=MA-VA-MEDI3250-1116&attachmentIdentifier=e0d0f524-6632-4915-9806-fd62d9703860&fileName=Redacted_CSR_Synopsis.pdf&versionIdentifier=', 'label': 'redacted CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.', 'detailedDescription': 'This post-marketing study will enroll approximately 5,200 subjects 2-17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness. This study will begin in the fall of 2013 and will be completed after 4 influenza seasons (i.e.after the 2016-2017 influenza season). No investigational product will be administered in this study. A nasal swab will be obtained and tested for the presence of influenza virus and other viral pathogens. This study will be conducted at 4 sites in the United States of America. The duration of study participation for each subject is one day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects 2 to 17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Community-dwelling children and adolescents 2 to 17 years of age.\n* Written Informed Consent or Assent.\n* Acute respiratory illness documented at study visit or at home with fever (oral temperature ≥ 100.0° Fahrenheit at study visit, or history of fever reported by parents, or use of antipyretic prior to study visit)\n* Symptom onset less than 5 days prior to study visit.\n* Subject and/or subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator.\n\nExclusion Criteria:\n\n* Treatment with an antiviral drug for influenza (oseltamivir or Tamiflu®, zanamivir or Relenza®) during the 14 days before enrollment\n* Any condition that, in the opinion of the investigator, would interfere with interpretation of subject safety or study results\n* Concurrent enrollment in another clinical study\n\nPatient already enrolled during this influenza season\n\n* Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals."}, 'identificationModule': {'nctId': 'NCT01997450', 'acronym': 'ICICLE', 'briefTitle': 'A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age', 'orgStudyIdInfo': {'id': 'MA-VA-MEDI3250-1116'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Q/LAIV', 'description': 'FluMist Quadrivalent'}, {'label': 'Inactivated Influenza Vaccine', 'description': 'Inactivated Influenza Vaccine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '55440', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44308-1063', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': 'BS2 8AE', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'OX3 7EJ', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SW17 0QT', 'city': 'Tooting', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.42524, 'lon': -0.16394}}], 'overallOfficials': [{'name': 'Herve Caspard, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}