Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-28 @ 10:07 PM
Study NCT ID:
NCT01467934
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2011-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mss2112@columbia.edu', 'phone': '212-342-5732', 'title': 'Melissa Stockwell', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 days', 'description': 'medical record review', 'eventGroups': [{'id': 'EG000', 'title': 'Trivalent Inactivated Influenza Vaccine (TIV) Alone', 'description': 'Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1', 'otherNumAtRisk': 208, 'otherNumAffected': 0, 'seriousNumAtRisk': 208, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TIV and PCV13 Together', 'description': 'Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1', 'otherNumAtRisk': 212, 'otherNumAffected': 0, 'seriousNumAtRisk': 212, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone', 'description': '13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1', 'otherNumAtRisk': 110, 'otherNumAffected': 0, 'seriousNumAtRisk': 110, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fever >= 100.4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Trivalent Inactivated Influenza Vaccine (TIV) Alone', 'description': 'Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1'}, {'id': 'OG001', 'title': 'TIV and PCV13 Together', 'description': 'Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1'}, {'id': 'OG002', 'title': '13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone', 'description': '13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '37.6', 'groupId': 'OG001'}, {'value': '9.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in analysis included those for whom both day 0 and day 1 temperature data was reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trivalent Inactivated Influenza Vaccine (TIV) Alone', 'description': 'Trivalent inactivated influenza vaccine 0.25ml IM X 1'}, {'id': 'FG001', 'title': 'TIV and PCV13 Together', 'description': 'Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1'}, {'id': 'FG002', 'title': '13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone', 'description': '13-valent pneumococcal conjugate vaccine (PCV13) 0.5ml IM x 1'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '212'}, {'groupId': 'FG002', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '212'}, {'groupId': 'FG002', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '530', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Trivalent Inactivated Influenza Vaccine (TIV) Alone', 'description': 'Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1'}, {'id': 'BG001', 'title': 'TIV and PCV13 Together', 'description': 'Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1'}, {'id': 'BG002', 'title': '13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone', 'description': '13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '6-11 months', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '287', 'groupId': 'BG003'}]}]}, {'title': '12-23 months', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '263', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '267', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Latino', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '458', 'groupId': 'BG003'}]}]}, {'title': 'Black Latino', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}, {'title': 'White non-Latino', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Other non-Latino', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 530}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-19', 'studyFirstSubmitDate': '2011-11-07', 'resultsFirstSubmitDate': '2014-06-22', 'studyFirstSubmitQcDate': '2011-11-08', 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-19', 'studyFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fever >= 100.4', 'timeFrame': '8 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fever']}, 'referencesModule': {'references': [{'pmid': '24395025', 'type': 'DERIVED', 'citation': 'Stockwell MS, Broder K, LaRussa P, Lewis P, Fernandez N, Sharma D, Barrett A, Sosa J, Vellozzi C. Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine. JAMA Pediatr. 2014 Mar;168(3):211-9. doi: 10.1001/jamapediatrics.2013.4469.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will prospectively assess fever rates and other associated vaccine adverse events in 6-23 month old patients during days 0-7 after administration of trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) concomitantly compared to those who receive trivalent inactivated influenza vaccine (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) administered non-concomitantly. The investigators hypothesize that fever rates will be significantly higher during the 0-1 days after vaccination when inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) are given concomitantly than when TIV or PCV13 is administered non-concomitantly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '6-23 months old visiting study sites', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. are 6 through 23 month olds,\n2. have a visit at a study site during the study period of Nov. 1, 2011 through March 31, 2012,\n3. receive trivalent inactivated influenza vaccine (TIV)/13-valent pneumococcal conjugate vaccine (PCV13)concomitantly, trivalent inactivated influenza vaccine (TIV)/without 13-valent pneumococcal conjugate vaccine (PCV13) or 13-valent pneumococcal conjugate vaccine (PCV13) without trivalent inactivated influenza vaccine (TIV)/(4) parent has a cell phone with text messaging capabilities; and\n\n(5) parent speaks English or Spanish.\n\nExclusion criteria:\n\n1. presence of fever \\>=100.4 at time of vaccination;\n2. administration of any antipyretic in the 6-hour period prior to vaccination\n3. stated intent to use prophylactic antipyretics at time of vaccination before the development of a fever;\n4. stated intention to move away from the NYC area \\<6 month;\n5. parent only speaks a language other than English or Spanish;\n6. inability to read text messages;\n7. children who received live attenuated influenza vaccine (LAIV) this visit;\n8. children who received trivalent inactivated influenza vaccine (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) in the seven days prior to enrollment date\n\nNote: Patient may receive other vaccines in addition to trivalent inactivated influenza vaccine (TIV)/13-valent pneumococcal conjugate vaccine (PCV13)'}, 'identificationModule': {'nctId': 'NCT01467934', 'briefTitle': 'FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'FeverText: Assessing Fever Rates After Influenza and Pneumococcal Vaccination During the 2011-12 Influenza Season Using Text Messaging', 'orgStudyIdInfo': {'id': 'AAAJ0504'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trivalent inactivated influenza vaccine', 'description': 'Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1'}, {'label': 'TIV and PCV13 together', 'description': 'Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1'}, {'label': '13-valent pneumococcal conjugate vaccine', 'description': '13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30333', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Centers for Disease Control and Prevention', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Melissa Stockwell, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Philip LaRussa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Karen Broder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics and Population and Family Health', 'investigatorFullName': 'Melissa Stockwell, MD, MPH', 'investigatorAffiliation': 'Columbia University'}}}}