Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-01-04 @ 4:07 PM
Study NCT ID:
NCT00700193
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2008-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population
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': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'lastUpdateSubmitDate': '2016-07-17', 'studyFirstSubmitDate': '2008-06-17', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of CSL Influenza Virus Vaccine in a Paediatric population through the assessment of the frequency of Local and general solicited symptoms, Unsolicited Adverse Events (UAE),Serious Adverse Events (SAEs)', 'timeFrame': 'Local & general solicited symptoms for 7 days post each vaccination, UAEs for 30 days post each vaccination, SAEs for 6 months after the last primary vaccination and 6 months after the booster vaccination'}], 'secondaryOutcomes': [{'measure': 'Evaluate immunogenicity response to CSL Influenza Virus Vaccine in Paediatric population according to the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines', 'timeFrame': '30 days after each vaccine dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the Safety, Tolerability \\& Immunogenicity of CSL Limited's Influenza Virus Vaccine in a two dose primary vaccination series, with a 12-month booster vaccination, in a paediatric population equal to or greater than 6 months to less than 9 years old."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be healthy male or female children, aged = or \\> 6 months to \\< 9 years at the time of first study vaccination; Note: = or \\> 6 refers to 6 calendar months\n2. Parent(s) or Guardian(s) to provide written informed consent to participate in the study;\n3. Be able to provide a pre-vaccination sample of up to 5mL of venous blood without undue distress/discomfort and\n4. Be born after a normal gestation period (between 36 and 42 weeks).\n\nExclusion Criteria:\n\n1. Known allergy to eggs, chicken feathers, neomycin, polymyxin, or any components of the vaccine;\n2. Previous influenza vaccination;\n3. Clinical signs of active infection and/or an axillary temperature of = or \\>37.5 degrees Celsius or oral temperature of = or \\>38 degrees Celsius at study entry. Study entry may be deferred for such individuals, at the discretion of the Principal Investigator;\n4. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder (including HIV);\n5. Current (or within the 90 days prior to receiving the Study Vaccine) treatment with immunosuppressive or immunomodulative medication, including systemic corticosteroids, as follows:\n\n •Chronic or long term corticosteroids: \\>0.5mg/kg/day of oral prednisolone or equivalent (Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable).\n6. Administration of immunoglobulins and/or any blood products since birth or planned administration of such blood products during the study period;\n7. Participation in a clinical study or use of an investigational compound (ie a new chemical or biological entity not registered for clinical use), within the 90 days prior to receiving the Study Vaccine or be planning to enter such a study during the study period;\n8. Current treatment with cytotoxic drugs or treatment within the 6 months prior to administration of the Study Vaccine;\n9. Have a known history of Guillain-Barré Syndrome;\n10. Have a major congenital defect or serious illness and\n11. Have a history of neurologic disorders or seizures'}, 'identificationModule': {'nctId': 'NCT00700193', 'briefTitle': "A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population", 'organization': {'class': 'INDUSTRY', 'fullName': 'Seqirus'}, 'officialTitle': "An Open-Label, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of CSL's Influenza Vaccine in a Paediatric Population (= or >6 Months to < 9 Years of Age).", 'orgStudyIdInfo': {'id': 'CSLCT-FLU-04-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A', 'description': 'Equal to or greater 6 months to less than 3 years old', 'interventionNames': ['Biological: Influenza Virus Vaccine']}, {'type': 'OTHER', 'label': 'Group B', 'description': 'Equal to or greater 3 years to less than 9 years old', 'interventionNames': ['Biological: Influenza Virus Vaccine']}], 'interventions': [{'name': 'Influenza Virus Vaccine', 'type': 'BIOLOGICAL', 'description': '2 dose vaccine regimen: 2 X 0.25mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose', 'armGroupLabels': ['Group A']}, {'name': 'Influenza Virus Vaccine', 'type': 'BIOLOGICAL', 'description': '2 dose vaccine regimen: 2 X 0.50mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3052', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Murdoch Childrens Research Institute', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Terry M Nolan, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Murdoch Childrens Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seqirus', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Russell Basser', 'oldOrganization': 'CSL Limited'}}}}