Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-02-22 @ 7:05 AM
Study NCT ID:
NCT02000466
Status:
WITHDRAWN
Last Update Posted:
2014-10-27
First Post:
2013-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FluLaval® Quadrivalent Pregnancy Registry
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'GSK has merged all individual pregnancy registries, which are terminated, for its seasonal influenza vaccines into one combined registry, EPI-FLU-039 VS US PR.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-23', 'studyFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2013-11-27', 'lastUpdatePostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent during pregnancy or within 28 days preceding conception', 'timeFrame': 'Up to 12 months after EDD'}]}, 'conditionsModule': {'keywords': ['Women', 'Pregnancy exposure', 'FluLaval Quadrivalent', 'Pregnancy outcome', 'Pregnancy Registry'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'The purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with FluLaval Quadrivalent. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with FluLaval Quadrivalent during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively.', 'detailedDescription': 'Some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). The Registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports.\n\nPregnancy outcome data will be collected using questionnaires within 3 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD from 30 November 2013 to 31 May 2018.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '64 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women, residing in the US, exposed to FluLaval Quadrivalent and who are volunteering to take part in the Pregnancy Registry before the outcome of the pregnancy is known.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA subject will be included in the Registry if all of the following criteria are met:\n\n* Exposure to vaccine occurs during pregnancy or within 28 days preceding conception.\n* Subject is a US resident.\n* A HCP is identified (name, address and phone number).\n* Subject can be identified (by GSK or HCP).\n\nData from registered subjects will be included in the analyses if the following criterion is met:\n\n• Pregnancy is ongoing and the outcome is unknown.\n\nExclusion Criteria:\n\nData from registered subjects will not be included in the analyses if the following criterion is met:\n\n• Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. Pregnancies in which prenatal testing indicates a normal pregnancy would also be excluded because inclusion of such pregnancies could potentially bias results toward a lower overall estimate of risk for defects. Typically pregnancies \\> 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.'}, 'identificationModule': {'nctId': 'NCT02000466', 'briefTitle': 'FluLaval® Quadrivalent Pregnancy Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'FluLaval® Quadrivalent Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Any Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With FluLaval® Quadrivalent During Pregnancy or Within 28 Days Preceding Conception', 'orgStudyIdInfo': {'id': '201086'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed cohort', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Initial and follow-up data will be collected using questionnaires', 'armGroupLabels': ['Exposed cohort']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}