Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT01289418
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2011-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Surveillance for Adverse Events Following Pandemic H1N1 Immunization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gaston.deserres@ssss.gouv.qc.ca', 'phone': '418-666-7000', 'title': 'Gaston De Serres', 'phoneExt': '274', 'organization': 'Laval University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "Only 52% answered the 3 surveys. We don't know why 48% didn't complete the 3 surveys (were they too sick or not motivated).We didn't have a group of comparable unvaccinated individuals (to estimate the risks attributable to the vaccine)."}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Health Care Workers From CHUQ Hospitals', 'otherNumAtRisk': 4984, 'otherNumAffected': 383, 'seriousNumAtRisk': 3064, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Local reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4984, 'numEvents': 39, 'numAffected': 39}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4984, 'numEvents': 70, 'numAffected': 70}], 'organSystem': 'General disorders'}, {'term': 'respiratory problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4984, 'numEvents': 201, 'numAffected': 201}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4984, 'numEvents': 73, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'pancreas cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders'}, {'term': 'cervix precancerous cells', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'gynecologic problems/obstetrical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions'}, {'term': 'gynecologic problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'cutaneous infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'toxic shock syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'abdominal problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Musculoskeletal problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Chronic pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Eye problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'ear surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'severe headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Vaso-vasectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'no diagnosis', 'notes': 'intermittent pain in the arm.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3064, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6242', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Health Care Workers', 'description': 'Health care workers with a valid e-mail address'}], 'classes': [{'categories': [{'measurements': [{'value': '234', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at day 8, 15 and 29', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6242', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Health Care Workers', 'description': 'Health care workers with a valid email address'}], 'classes': [{'categories': [{'measurements': [{'value': '374', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 8, 15 and 29', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'the Occurrence of Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3064', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Health Care Workers From CHUQ Hospitals'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Health Care Workers', 'description': 'Health care workers from all hospitals'}], 'periods': [{'title': 'Day 8 Survey', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6525'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4307'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2218'}]}], 'dropWithdraws': [{'type': 'email address invalid', 'reasons': [{'groupId': 'FG000', 'numSubjects': '283'}]}, {'type': 'participants did not complete the survey', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1935'}]}]}, {'title': 'Day 29 Survey', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6525'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4057'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2468'}]}], 'dropWithdraws': [{'type': 'email address invalid', 'reasons': [{'groupId': 'FG000', 'numSubjects': '283'}]}, {'type': 'participants did not complete the survey', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2185'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5183', 'groupId': 'BG000'}, {'value': '519', 'groupId': 'BG001'}, {'value': '823', 'groupId': 'BG002'}, {'value': '6525', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Health Care Workers in Quebec', 'description': 'Health care workers from Quebec'}, {'id': 'BG001', 'title': 'Health Care Workers in Toronto', 'description': 'Health Care Workers from Toronto'}, {'id': 'BG002', 'title': 'Health Care Workers in Halifax', 'description': 'Health Care Workers from Halifax'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '3152', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG002'}, {'value': '3152', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': "Demographic data was collected in only one site (n=3159). Some participants did not complete all the questions. That's why we don't have the age and the gender for all the participants.", 'unitOfMeasure': 'participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'spread': '11.7', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG002'}, {'value': '37.5', 'spread': '11.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '2310', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG002'}, {'value': '2310', 'groupId': 'BG003'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '841', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'demographic data were available only for Quebec', 'groupId': 'BG002'}, {'value': '841', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': "Demographic data was collected in only one site (n=3159). Some participants did not complete all the questions. That's why we don't have the age and the gender for all the participants.", 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '5183', 'groupId': 'BG000'}, {'value': '519', 'groupId': 'BG001'}, {'value': '823', 'groupId': 'BG002'}, {'value': '6525', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6525}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-15', 'studyFirstSubmitDate': '2011-02-02', 'resultsFirstSubmitDate': '2012-07-09', 'studyFirstSubmitQcDate': '2011-02-02', 'lastUpdatePostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-09', 'studyFirstPostDateStruct': {'date': '2011-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.', 'timeFrame': 'at day 8, 15 and 29'}, {'measure': 'Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.', 'timeFrame': 'day 8, 15 and 29'}, {'measure': 'the Occurrence of Serious Adverse Events (SAE)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['H1N1', 'vaccine safety', 'adverse events', 'health care workers'], 'conditions': ['Novel Influenza A/H1N1']}, 'referencesModule': {'references': [{'pmid': '22802929', 'type': 'DERIVED', 'citation': 'De Serres G, Gariepy MC, Coleman B, Rouleau I, McNeil S, Benoit M, McGeer A, Ambrose A, Needham J, Bergeron C, Grenier C, Sleigh K, Kallos A, Ouakki M, Ouhoummane N, Stiver G, Valiquette L, McCarthy A, Bettinger J; PHAC-CIHR influenza Research Network (PCIRN). Short and long-term safety of the 2009 AS03-adjuvanted pandemic vaccine. PLoS One. 2012;7(7):e38563. doi: 10.1371/journal.pone.0038563. Epub 2012 Jul 3.'}]}, 'descriptionModule': {'briefSummary': 'Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or drifts, and its safety profile may vary. While generally considered safe, influenza vaccines have been associated in the past with increases in cases of Guillain-Barré syndrome (1976) or with oculorespiratory syndrome (2001). The emergence of a novel strain of H1N1 influenza virus (pH1N1) has prompted health departments worldwide to prepare for mass vaccination campaigns with a new H1N1 pandemic vaccine. Following recommendations of the World Health Organization (WHO), Canada immunized its population with a dose-sparing adjuvanted vaccine. While the adjuvant developed by GlaxoSmithKline (GSK) has been administered to over 39 000 people, only a few hundred will have been vaccinated with the H1N1 formulation in clinical trials before the mass campaign was launched. With this small number, adverse events occurring at a rate \\< 1% will not be detected by these clinical trials.\n\nConsidering that most cases of pH1N1 to date have been relatively mild, it will be imperative to rapidly detect adverse events serious enough to reconsider the use of the vaccine. Passive surveillance is collecting notifications of adverse events but the sensitivity of this system is not high and its timeliness is not necessarily optimal.\n\nIn Canada, healthcare workers (HCW) are among those who were offered the new pandemic vaccine in priority. Because they were offered the vaccine early in the campaign and because they constitute a well-defined group in good general health, this group of people may be well suited for monitoring the safety of the pH1N1 vaccine.\n\nThe main objective of this project was to estimate in HCW vaccinated against pH1N1 the frequency of adverse events of sufficient severity to cause work absenteeism or medical consultation.\n\nThe active surveillance was done in HCW from 3 sites (Canadian hospitals) participating in the Pandemic Influenza Research Network (PCIRN): (1) Halifax (Nova Scotia), (2) Quebec City (Quebec): 3 hospitals, (3) Toronto'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The active surveillance was conducted in three Canadian hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research- Influenza Research Network (PCIRN): Quebec City, Toronto, and Halifax. Healthcare workers immunized in these institutions were offered to participate in a web-based active surveillance of vaccine safety.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be a health care worker from one of the three Canadian Hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research- Influenza Research Network (PCIRN): Quebec City, Toronto, and Halifax.\n* To have been immunized with the pH1N1 vaccine.\n* To have an email address.\n* To be 18 years old and older.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01289418', 'briefTitle': 'Surveillance for Adverse Events Following Pandemic H1N1 Immunization', 'organization': {'class': 'OTHER_GOV', 'fullName': 'PHAC/CIHR Influenza Research Network'}, 'officialTitle': 'Short and Long-Term Electronic Surveillance of a Large Number of Healthcare Workers Following Administration of an Adjuvanted Ph1n1 Vaccine', 'orgStudyIdInfo': {'id': 'pcirn-surveillancehcw-0910'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health care workers in Québec', 'description': 'Health care workers from CHUQ hospitals'}, {'label': 'Health care workers in Toronto', 'description': 'Health care workers from the Mount Sinai Hospital'}, {'label': 'Health care workers in Halifax', 'description': 'Health care workers from the Queen Elizabeth Hospital'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gaston De Serres, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut National en Santé Publique du Québec'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PHAC/CIHR Influenza Research Network', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Institut National en Santé Publique du Québec', 'class': 'OTHER'}, {'name': 'Laval University', 'class': 'OTHER'}, {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, {'name': 'Queen Elizabeth II Health Sciences Centre', 'class': 'OTHER'}, {'name': 'Mount Sinai Hospital, New York', 'class': 'OTHER'}, {'name': 'The Ottawa Hospital', 'class': 'OTHER'}, {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, {'name': "Alberta Children's Hospital", 'class': 'OTHER'}, {'name': 'Vancouver General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Epidemiologist at the National Institute of Public Health of Quebec and professor of epidemiology at the University Laval', 'investigatorFullName': 'Gaston De Serres', 'investigatorAffiliation': 'Laval University'}}}}