Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT01512056
Status:
UNKNOWN
Last Update Posted:
2012-01-19
First Post:
2011-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D006679', 'term': 'HIV Seropositivity'}], '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'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-13', 'studyFirstSubmitDate': '2011-11-01', 'studyFirstSubmitQcDate': '2012-01-13', 'lastUpdatePostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of antibody titer before and after influenza vaccination', 'timeFrame': '18 weeks', 'description': 'The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay will also be used to evaluate the immune response post vaccination. The immune response based on microNT-ELISA antibody titers would be reported as antibody titer ≥1: 40 or ≥ 1:160 respectively because no threshold of protective NT antibody titer is clearly defined by the international guidelines.'}], 'secondaryOutcomes': [{'measure': 'Seroresponse rate', 'timeFrame': '0, 3 weeks, 6 weeks, 9 weeks and 18 weeks', 'description': 'The seroconversion is defined as the HI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HI serum titer or a four-fold or greater increase in HI titers in subjects who had a positive pre-vaccination HAI serum titer.'}, {'measure': 'Seroresponse rate', 'timeFrame': '0, 3 weeks, 6 weeks, 9 weeks and 18 weeks', 'description': 'The seroresponse is defined as HI or micro-NT titer of the post-vaccination serum is at least 4-fold increase of the HI or micro-NT titer after vaccination.\n\nGeometric mean folds increase in HI or micro-NT titer.'}, {'measure': 'the safety and tolerability profiles of the vaccine', 'timeFrame': '0, 3 week, 6 weeks, 9 weeks, 18 weeks', 'description': 'evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza vaccine', 'dialysis', 'vaccine', 'Seroprotection', 'Seroresponse', 'Seroconversion', 'Safety of the vaccine'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012).', 'detailedDescription': 'The immune response to influenza vaccine was poor in dialysis population than general population. The investigators want to evaluate another booster vaccination can improve the immune response in dialysis population. All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). The investigators will collect serum of participants 3 weeks, 6 weeks, 9 weeks and 18 weeks post vaccination and evaluate the difference of immune response in these 3 groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and non-pregnant females and aged more than 18 years;\n2. Willing and able to adhere to visit schedules and all study requirements;\n3. Subjects read and signed the study-specific informed consent.\n\nExclusion Criteria:\n\n1. Subject or his/her family is employed by the participated hospital;\n2. Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;\n3. History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;\n4. Personal or family history of Guillain-Barré Syndrome;\n5. An acute febrile illness within 1 week prior to vaccination;\n6. Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;\n7. Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;\n8. Female subjects who are pregnant during the study.\n9. Patients who receive hemodialysis therapy less than 3 months.\n10. Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;\n11. Immunodeficiency, or under immunosuppressive treatment.\n12. Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);\n13. Receipt of any blood products, including immunoglobulin in the prior 3 months;\n14. Any severe illness needed to be hospitalization within three months.\n15. Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine."}, 'identificationModule': {'nctId': 'NCT01512056', 'briefTitle': 'Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients', 'orgStudyIdInfo': {'id': 'BR-100-086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the immunogenicity profiles of the AdimFlu-S', 'description': 'Experimental group: to receive either only one dose of influenza vaccine at day 0 or one more booster vaccination 3 weeks later.\n\nNegative control group: dialysis patients who refused to receive influenza vaccination.', 'interventionNames': ['Drug: AdimFlu-S']}, {'type': 'NO_INTERVENTION', 'label': 'The safety outcome of the vaccine', 'description': 'Any adverse effect, including systemic or local site, will be recorded during the study period.'}], 'interventions': [{'name': 'AdimFlu-S', 'type': 'DRUG', 'description': 'All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). Each dose of vaccine contains 15μg antigen of each virus strain suggested by WHO (A/California/7/2009 (H1N1);A/Perth/16/2009 (H3N2);B/Brisbane/60/2008).', 'armGroupLabels': ['the immunogenicity profiles of the AdimFlu-S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '704', 'city': 'Tainan', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Junne Ming Sung, MD', 'role': 'CONTACT', 'email': 'jmsung@mail.ncku.edu.tw', 'phone': '886-6-2353535', 'phoneExt': '2594'}, {'name': 'Yu Tzu Chang, MD and Msc', 'role': 'CONTACT', 'email': 'kangxiemperor@gmail.com', 'phone': '886-6-2353535', 'phoneExt': '2593'}, {'name': 'Junne Ming Sung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yu Tzu Chang, MD and Msc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yi Ching Yang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Meng Te Lin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Junne Ming Sung, MD', 'role': 'CONTACT', 'email': 'jmsung@mail.ncku.edu.tw', 'phone': '886-6-2353535', 'phoneExt': '2594'}, {'name': 'Yu Tzu Chang, MD and Msc', 'role': 'CONTACT', 'email': 'kangxiemperor@gmail.com', 'phone': '886-6-2353535', 'phoneExt': '2593'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}