Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:00 AM
Study NCT ID:
NCT01100294
Status:
COMPLETED
Last Update Posted:
2012-05-21
First Post:
2010-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
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': 'D014611', 'term': 'Vaccination'}, {'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D016233', 'term': 'Immunotherapy, Active'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-18', 'studyFirstSubmitDate': '2010-03-30', 'studyFirstSubmitQcDate': '2010-04-07', 'lastUpdatePostDateStruct': {'date': '2012-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '28 days after vaccination', 'description': 'To assess tolerability/safety (incidence of adverse events) of the study drug after Day 28 following the vaccination.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '180-210 days after vaccination', 'description': 'To assess safety of the study drug after Day 180-210 following the vaccination.'}, {'measure': 'Efficacy of the study drug', 'timeFrame': '180-210 days after vaccination', 'description': 'To assess the efficacy of the study drug by epidemiological follow-up of the participants until Day 180-210 following the vaccination.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Influenza', 'Pandemic vaccine', 'Seasonal vaccine', 'Prevention', 'Influenza vaccine', 'Influenza in humans', 'Pandemic influenza in humans', 'Influenza vaccine for children'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.', 'detailedDescription': 'This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not repeated.\n\nTolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children aged 6 to 36 months, both sexes;\n* Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study;\n* Capability of the legitimate representative of the volunteer to understand and comply with planned study procedures;\n* Legitimate representative of the volunteer provide written informed consent prior to initiation of study procedures;\n* Absence of existence of any exclusion criteria.\n\nExclusion Criteria:\n\n* Known allergy to eggs or other components of the vaccine (in particular mercury);\n* History of Guillain-Barré syndrome;\n* Active neoplasm;\n* Former or on-going immunosuppressive therapy;\n* Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;\n* Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;\n* Documented HIV, HBV or HCV infection;\n* Chronic illness that, in the opinion of the investigator, may have effect on the participation in the study;\n* Acute febrile respiratory illness within one week prior to vaccination;\n* Vaccine therapy within 4 weeks prior to vaccination;\n* Influenza vaccination within 6 months prior to vaccination;\n* Experimental drug therapy within 1 month prior to vaccination;\n* Past or current psychiatric disease of the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the legitimate representative;\n* Alcohol or drug abuse of the legitimate representative."}, 'identificationModule': {'nctId': 'NCT01100294', 'briefTitle': 'Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fluart Innovative Vaccine Ltd, Hungary'}, 'officialTitle': 'Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children', 'orgStudyIdInfo': {'id': 'FLUVAL P-H-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccination with Fluval P', 'description': 'Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose.', 'interventionNames': ['Biological: Vaccination with FLUVAL P']}], 'interventions': [{'name': 'Vaccination with FLUVAL P', 'type': 'BIOLOGICAL', 'otherNames': ['Influenza', 'Pandemic vaccine', 'Prevention', 'Influenza vaccine', 'Influenza in humans', 'Vaccination of children'], 'description': 'Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant.\n\nDose: 0.25 ml (total 3 μg HA), single dose.', 'armGroupLabels': ['Vaccination with Fluval P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Veszprém', 'state': 'Veszprém megye', 'country': 'Hungary', 'facility': '"Csolnoky Ferenc" Veszprém County Hospital', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}], 'overallOfficials': [{'name': 'Anna Ősi, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Omninvest Ltd.'}, {'name': 'Éva Szabó, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Csolnoky Ferenc" Veszprém County Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fluart Innovative Vaccine Ltd, Hungary', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}