Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT04760132
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2021-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines (ENFORCE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2021-02-08', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the effectiveness of citizens being vaccinated with one of the SARS-CoV-2 vaccines', 'timeFrame': 'The change from Base-line in MPNAT measured via profiling of antibodies against SARS-CoV-2 Spike epitopes at 24 month', 'description': 'Primary outcome is the minimal protective neutralising antibody titre (MPNAT); i.e. the minimum level of neutralising antibodies sufficient to protect the person from becoming infected.'}], 'secondaryOutcomes': [{'measure': 'Number of breakthrough infections in the 24 months period will be used to compare the effectiveness between the vaccines', 'timeFrame': 'The change from first vaccination until 24 month', 'description': 'Number of confirmed positive SARS-CoV-2 tests reported via the national testing system.'}, {'measure': 'Assessment of the safety of the vaccines will be compared between groups', 'timeFrame': 'From first vaccine until Day 90', 'description': 'Reports of participants with local and systemic reactions to the vaccination will be collected'}, {'measure': 'Assessment of any Adverse Event from the vaccines will be compared between groups', 'timeFrame': 'From first vaccine until Day 90', 'description': 'Reports of participants with grade 3 and 4 Adverse Events and any Serious Adverse will be collected'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Vaccination'], 'conditions': ['SARS-CoV Infection']}, 'referencesModule': {'references': [{'pmid': '36585137', 'type': 'DERIVED', 'citation': 'Staerke NB, Reekie J, Johansen IS, Nielsen H, Benfield T, Wiese L, Sogaard OS, Tolstrup M, Iversen KK, Tarp B, Larsen FD, Larsen L, Lindvig SO, Holden IK, Iversen MB, Knudsen LS, Fogh K, Jakobsen ML, Traytel AK, Ostergaard L, Lundgren J; ENFORCE Study Group. Cohort Profile:The Danish National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines (ENFORCE). BMJ Open. 2022 Dec 30;12(12):e069065. doi: 10.1136/bmjopen-2022-069065.'}]}, 'descriptionModule': {'briefSummary': 'National cohort study of effectiveness and safety of SARS-CoV-2 vaccines (ENFORCE is an equivalence trial to evaluate the effectiveness and safety of multiple new SARS-CoV-2 vaccines approved for use in the EU, and which are being offered at participating units.\n\nThe design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls.\n\nA sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).', 'detailedDescription': 'First phase will enrol 10,000 persons initiating vaccination (assuming 4 vaccines). If more vaccines become available additional 2,500 persons per vaccine will be included. Subsequent phases with larger sections of the population included may be implemented.\n\nParticipants will have 6 study visits and be followed for 2 years after the first vaccination, which offers the participants an extra close follow up on vaccine effectiveness. Safety data will be collected at study visits until 3 months after the first vaccination. Research samples will be collected at each study visit during the two year follow-up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent obtained before any trial related procedures are performed\n2. Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan)\n3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples)\n\nExclusion Criteria:\n\n1. Male and female under the age of 18\n2. Any subgroup of individuals for which the vaccines are contraindicated\n3. Previous SARS-CoV-2 vaccination'}, 'identificationModule': {'nctId': 'NCT04760132', 'acronym': 'ENFORCE', 'briefTitle': 'National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines (ENFORCE)', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'National Cohort Study of Effectiveness and Safety of SARS-CoV-2/COVID-19 Vaccines', 'orgStudyIdInfo': {'id': 'ENFORCE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vaccine A - COMIRNATY COVID-19 vaccine', 'description': 'COMIRNATY (COVID-19, mRNA Vaccine) by BioNTech Manufacturing GmbH Marketing Authorisation EU/1/20/1528', 'interventionNames': ['Biological: COMIRNATY - BioNTech Manufacturing GmbH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vaccine B - Moderna COVID-19 vaccine', 'description': 'COVID-19 Vaccine Moderna dispersion for injection (COVID-19, mRNA Vaccine) by MODERNA BIOTECH SPAIN S.L.\n\nMarketing Authorisation EU/1/20/1507/001', 'interventionNames': ['Biological: COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vaccine C - Astra-Zeneca COVID-19 vaccine', 'description': 'COVID-19 Vaccine AstraZeneca suspension for injection (ChAdOx1-S \\[recombinant\\]) by AstraZeneca AB Marketing Authorisation EU/1/21/1529/001 and /002', 'interventionNames': ['Biological: COVID-19 Vaccine AstraZeneca suspension for injection']}], 'interventions': [{'name': 'COMIRNATY - BioNTech Manufacturing GmbH', 'type': 'BIOLOGICAL', 'description': 'Vaccination as part of the the Danish national government programme', 'armGroupLabels': ['Vaccine A - COMIRNATY COVID-19 vaccine']}, {'name': 'COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH', 'type': 'BIOLOGICAL', 'description': 'Vaccination as part of the the Danish national government programme', 'armGroupLabels': ['Vaccine B - Moderna COVID-19 vaccine']}, {'name': 'COVID-19 Vaccine AstraZeneca suspension for injection', 'type': 'BIOLOGICAL', 'description': 'Vaccination as part of the the Danish national government programme', 'armGroupLabels': ['Vaccine C - Astra-Zeneca COVID-19 vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Aarhus N', 'country': 'Denmark', 'facility': 'Aarhus Universitetshospital, Skejby', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg Universityhospital Syd', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '2600', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense Universityhospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Sjællandsuniversitetshospital', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'overallOfficials': [{'name': 'Jens Lundgren, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens D Lundgren, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of the Interior and Health, Denmark', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jens D Lundgren, MD', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}