Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT00710866
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2008-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity
Sponsor:
Organization:
Raw JSON
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'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Miscellaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.5mL VAXIGRIP®', 'description': '2 doses 0.5mL VAXIGRIP® at months 0, 1'}, {'id': 'OG001', 'title': '0.25mL VAXIGRIP®', 'description': '2 doses 0.25mL VAXIGRIP® at months 0, 1'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '15.2'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '12.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '27-46 days after the second dose', 'description': 'Seroprotection rate: HI titers =\\>40', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 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VAXIGRIP®', 'description': '2 doses 0.5mL VAXIGRIP® at months 0, 1'}, {'id': 'OG001', 'title': '0.25mL VAXIGRIP®', 'description': '2 doses 0.25mL VAXIGRIP® at months 0, 1'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '15.7'}, {'value': '52', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '11.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '27-46 days after the second dose', 'description': 'Seroprotection rate: HI titers =\\>40', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol', 'anticipatedPostingDate': '2012-01'}, {'type': 'PRIMARY', 'title': 'Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '0.5mL VAXIGRIP®', 'description': '2 doses 0.5mL VAXIGRIP® at months 0, 1'}, {'id': 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'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-11', 'studyFirstSubmitDate': '2008-07-07', 'resultsFirstSubmitDate': '2011-07-11', 'studyFirstSubmitQcDate': '2008-07-07', 'lastUpdatePostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-11', 'studyFirstPostDateStruct': {'date': '2008-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)', 'timeFrame': '27-46 days after the second dose', 'description': 'Seroprotection rate: HI titers =\\>40'}, {'measure': 'Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)', 'timeFrame': '27-46 days after the second dose', 'description': 'Seroprotection rate: HI titers =\\>40'}, {'measure': 'Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)', 'timeFrame': '27-46 days after the second dose', 'description': 'Seroprotection rate: HI titers =\\>40'}, {'measure': 'Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)', 'timeFrame': '27-46 days after the second dose', 'description': 'Seroprotection rate: HI titers =\\>40'}, {'measure': 'Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)', 'timeFrame': '27-46 days after the second dose'}, {'measure': 'Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)', 'timeFrame': '27-46 days after the second dose', 'description': 'Seroprotection rate: HI titers =\\>40'}, {'measure': 'Adverse Events: Fever After Either Dose - Infants 6-11 Months', 'timeFrame': '3 days after immunization', 'description': 'Fever defined as temperature \\>= 38 C'}, {'measure': 'Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-', 'timeFrame': '3 days after immunization', 'description': 'Fever defined as temperature \\>= 38 C'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Influenza Vaccines', 'Infant', 'Dose-Response Relationship, Immunologic'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '21857263', 'type': 'DERIVED', 'citation': 'Skowronski DM, Hottes TS, De Serres G, Ward BJ, Janjua NZ, Sabaiduc S, Chan T, Petric M. Influenza Beta/Victoria antigen induces strong recall of Beta/Yamagata but lower Beta/Victoria response in children primed with two doses of Beta/Yamagata. Pediatr Infect Dis J. 2011 Oct;30(10):833-9. doi: 10.1097/INF.0b013e31822db4dc.'}, {'pmid': '21768314', 'type': 'DERIVED', 'citation': 'Skowronski DM, Hottes TS, Chong M, De Serres G, Scheifele DW, Ward BJ, Halperin SA, Janjua NZ, Chan T, Sabaiduc S, Petric M. Randomized controlled trial of dose response to influenza vaccine in children aged 6 to 23 months. Pediatrics. 2011 Aug;128(2):e276-89. doi: 10.1542/peds.2010-2777. Epub 2011 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination\n* Child between and including 6 months of age and 23 months of age (up to and including the day before 24 months of age)\n* Child is available and can complete all relevant procedures during the entire study period\n* Parent or legal guardian is available and can be reached by phone during the entire study period\n* Parent/guardian provides written informed consent\n* Parent/guardian is fluent in English\n\nExclusion Criteria:\n\n* Child has history of laboratory-confirmed influenza\n* Child has history of any prior influenza immunization\n* Child has history of anaphylactic reaction to any component of the vaccine (i.e. egg)\n* Child has received immune globulin or other blood products within the prior six weeks\n* Child has received injected or oral steroids within the prior six weeks (inhaled or topical steroids allowed)\n* Child has a bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopenia, coagulation disorder, anti-coagulant therapy)\n* Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period\n* Child is scheduled to receive a live vaccine (notably measles, mumps, rubella or varicella vaccines) during the study period\n* Child has a health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child'}, 'identificationModule': {'nctId': 'NCT00710866', 'acronym': 'TITRE', 'briefTitle': 'Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity', 'organization': {'class': 'OTHER_GOV', 'fullName': 'British Columbia Centre for Disease Control'}, 'orgStudyIdInfo': {'id': 'PHAC 6273-15-2008/4160872'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '2 doses 0.5mL VAXIGRIP® at months 0, 1', 'interventionNames': ['Biological: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '2 doses 0.25mL VAXIGRIP® at months 0, 1', 'interventionNames': ['Biological: Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)']}], 'interventions': [{'name': 'Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)', 'type': 'BIOLOGICAL', 'otherNames': ['VAXIGRIP®'], 'description': 'Arm 1 (experimental group) received two spaced injections of the 0.5 mL (full) dose while arm 2 (comparison group) received the currently recommended two spaced injections of 0.25mL (half) dose of trivalent inactivated split virion influenza vaccine (VAXIGRIP®) manufactured by Sanofi Pasteur, Lyon, France.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3C 4J2', 'city': 'Coquitlam', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.2846, 'lon': -122.78217}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vaccine Evaluation Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Dalhousie University / IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'H9H4Y6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre - Vaccine Study Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Université de Laval - Unité de recherche en santé publique', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Danuta M Skowronski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BC Centre for Disease Control'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British Columbia Centre for Disease Control', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Danuta M. Skowronski', 'oldOrganization': 'BC Centre for Disease Control'}}}}