Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-29 @ 6:23 PM
Study NCT ID:
NCT05060861
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2021-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Efficacy of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090985', 'term': 'ChAdOx1 nCoV-19'}], 'ancestors': [{'id': 'D019444', 'term': 'Vaccines, DNA'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-18', 'studyFirstSubmitDate': '2021-09-18', 'studyFirstSubmitQcDate': '2021-09-18', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis', 'timeFrame': 'up to one year', 'description': 'the frequency of breakthrough COVID-19 infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['safety', 'efficacy', 'immunogenicity', 'COVID-19 vaccine'], 'conditions': ['ChAdOx1 nCoV-19 Vaccine']}, 'descriptionModule': {'briefSummary': 'Since the beginning of COVID-19 pandemic, a safe and effective vaccine against infection and development of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is needed control of the wide spread of COVID-19 and reduce death rates throughout the world. Many clinical trials investigated the immunogenicity of different proposed vaccine including the first distributed vaccine; the ChAdOx1 nCoV-19 vaccine and there is a need to analyze the results of published clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants aged 18 years and older vaccinated by 2 doses of ChAdOx1 nCoV-19 vaccine', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant who received 2 doses of ChAdOx1 nCoV-19 vaccine\n\nExclusion Criteria:\n\n* non vaccinated person'}, 'identificationModule': {'nctId': 'NCT05060861', 'briefTitle': 'Safety, Efficacy of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Safety, Efficacy and Immunogenicity of Chadox1 Ncov-19 Vaccine: Rapid Systematic Review and Meta Analysis', 'orgStudyIdInfo': {'id': 'Assiut19'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ChAdOx1 nCoV-19 vaccine', 'type': 'OTHER', 'description': 'covid-19 vaccine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Aliae AR Mohamed-Hussein', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pulmonology', 'investigatorFullName': 'Aliae AR Mohamed Hussein', 'investigatorAffiliation': 'Assiut University'}}}}