Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01178918
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2010-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-specific Response to H1N1 Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2012-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-26', 'studyFirstSubmitDate': '2010-08-04', 'studyFirstSubmitQcDate': '2010-08-09', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination', 'timeFrame': 'At 3 weeks after vaccination'}, {'measure': 'T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination', 'timeFrame': 'At 11 weeks after vaccination.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza H1N1', 'Vaccine', 'Adjuvant', 'T Lymphocytes', 'Non-specific response', 'Interleukin-2', 'Non-specific T cell response'], 'conditions': ['Influenza H1N1']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study with recruitment of healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.\n\nThe purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1 vaccines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipients of H1N1 influenza vaccine.\n* Healthy individuals with no signs of influenza or other infectious disease.\n\nExclusion Criteria:\n\n* Signs of influenza or other infectious disease in 1 month before study participation.'}, 'identificationModule': {'nctId': 'NCT01178918', 'briefTitle': 'Non-specific Response to H1N1 Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'The University Clinic of Pulmonary and Allergic Diseases Golnik'}, 'officialTitle': 'Enhanced Non-Specific T Lymphocytes Response to Influenza A (H1N1) AS03-Adjuvanted Vaccine', 'orgStudyIdInfo': {'id': 'KOPA-H1N1-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers from recipients of H1N1 vaccine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4204', 'city': 'Golnik', 'country': 'Slovenia', 'facility': 'University Clinic of Respiratory and Allergic Diseases', 'geoPoint': {'lat': 46.33333, 'lon': 14.33333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University Clinic of Pulmonary and Allergic Diseases Golnik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Laboratory', 'investigatorFullName': 'Peter Korošec', 'investigatorAffiliation': 'The University Clinic of Pulmonary and Allergic Diseases Golnik'}}}}