Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-03-30 @ 11:24 PM
Study NCT ID:
NCT00660257
Status:
COMPLETED
Last Update Posted:
2008-04-17
First Post:
2008-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-16', 'studyFirstSubmitDate': '2008-04-15', 'studyFirstSubmitQcDate': '2008-04-16', 'lastUpdatePostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HI antibody Neutralization antibody', 'timeFrame': '15 and 30 days after the booster dose'}], 'secondaryOutcomes': [{'measure': 'local adverse reactions systemic adverse reactions temperature', 'timeFrame': '3 days after booster dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pandemic Influenza Vaccine', 'Prevention', 'Pandemic Influenza']}, 'referencesModule': {'references': [{'pmid': '19067606', 'type': 'DERIVED', 'citation': 'Lin JT, Li CG, Wang X, Su N, Liu Y, Qiu YZ, Yang M, Chen JT, Fang HH, Dong XP, Yin WD, Feng ZJ. Antibody persistence after 2-dose priming and booster response to a third dose of an inactivated, adjuvanted, whole-virion H5N1 vaccine. J Infect Dis. 2009 Jan 15;199(2):184-7. doi: 10.1086/595832.'}]}, 'descriptionModule': {'briefSummary': 'A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '61 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Had received two-dose priming vaccination in previous phase I trial\n* Be able to show legal identity card for the sake of recruitment\n* Be able to understand and sign the informed consent.\n\nExclusion Criteria:\n\n* Woman： Who breast-feeding or planning to become pregnant during the study\n* Any history of allergic reactions to vaccines or eggs\n* Autoimmune disease or immunodeficiency\n* Diabetes mellitus (type I or II), with the exception of gestational diabetes\n* Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years\n* Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment\n* Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study\n* Guillain-Barre Syndrome\n* Women subjects with positive urinary pregnancy test\n* Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months\n* History of any blood products administration within 3 months before the dosing\n* Administration of any other investigational research agents within 30 days before the dosing\n* Administration of any live attenuated vaccine within 30 days before the dosing\n* Administration of subunit or inactivated vaccines, e.g. pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing\n* Be receiving anti-TB prophylaxis or therapy currently\n* Axillary temperature \\>37.0 centigrade at the time of dosing\n* Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment\n* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent."}, 'identificationModule': {'nctId': 'NCT00660257', 'briefTitle': 'Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': 'Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza (H5N1)Vaccine in Two-Dose Primed Healthy Adults: A Single Center, Non-Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'PRO-PanFlu-1002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No.1: 1.25 ug', 'interventionNames': ['Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)']}, {'type': 'EXPERIMENTAL', 'label': 'No.2: 2.5 ug', 'interventionNames': ['Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)']}, {'type': 'EXPERIMENTAL', 'label': 'No.3: 5.0 ug', 'interventionNames': ['Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)']}, {'type': 'EXPERIMENTAL', 'label': 'No. 4: 10 ug', 'interventionNames': ['Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)']}], 'interventions': [{'name': 'pandemic influenza vaccine (H5N1 strain NIBRG-14)', 'type': 'BIOLOGICAL', 'description': 'pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection', 'armGroupLabels': ['No.1: 1.25 ug']}, {'name': 'pandemic influenza vaccine (H5N1 strain NIBRG-14)', 'type': 'BIOLOGICAL', 'description': 'pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection', 'armGroupLabels': ['No.2: 2.5 ug']}, {'name': 'pandemic influenza vaccine (H5N1 strain NIBRG-14)', 'type': 'BIOLOGICAL', 'description': 'pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection', 'armGroupLabels': ['No.3: 5.0 ug']}, {'name': 'pandemic influenza vaccine (H5N1 strain NIBRG-14)', 'type': 'BIOLOGICAL', 'description': 'pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection', 'armGroupLabels': ['No. 4: 10 ug']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention, China', 'class': 'OTHER_GOV'}]}}}