Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT06197802
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2023-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D003218', 'term': 'Condylomata Acuminata'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014860', 'term': 'Warts'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 392}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2023-12-26', 'studyFirstSubmitQcDate': '2023-12-26', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level', 'timeFrame': '30-36 months after the first dose', 'description': 'Anti-HPV 6,11,16,18,31,33,45,52 and 58 seropositive rates and geometric mean concentrations at months 30-36'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['human papillomavirus vaccine'], 'conditions': ['Cervical Cancer', 'Condylomata Acuminata']}, 'referencesModule': {'references': [{'pmid': '40919385', 'type': 'DERIVED', 'citation': 'Zhong GH, Bi ZF, Chu K, Zhang L, Chen L, Zhu KX, Quan JL, Nie C, Chen Q, Qiu LX, Xu JB, Li JX, Zhang ML, Liu S, Nie LL, Li K, Su YY, Huang SJ, Zhang QF, Huang WJ, Pan HX, Wu T, Zhang J, Xia NS. Immunogenicity comparison of an Escherichia coli-produced 9-valent human papillomavirus vaccine and Gardasil9 in Chinese women aged 18-26 years: three-year follow-up data from a randomised clinical trial. Lancet Reg Health West Pac. 2025 Aug 27;62:101671. doi: 10.1016/j.lanwpc.2025.101671. eCollection 2025 Sep.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to compare plateau antibody levels of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject who had previously participated in the Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck \\& Co., Inc.) in Healthy Females 18-26 Years of Age (Protocol No.: HPV-PRO-011, Identifiers: NCT04782895), and received at least one dose', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject who had previously participated in the Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck \\& Co., Inc.) in Healthy Females 18-26 Years of Age (Protocol No.: HPV-PRO-011, Identifiers: NCT04782895), and received at least one dose ;\n* Subject is able to understand and comply with the requirements of the protocol(e.g. biological specimen collection, return for follow-up visits), and written informed consent must be obtained from the subject prior to enrollment;\n\nExclusion Criteria:\n\n* Subject who had used other HPV vaccine products (including marketed and unmarketed vaccines) after participating in the Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck \\& Co., Inc.) in Healthy Females 18-26 Years of Age (Protocol No.: HPV-PRO-011, Identifiers: NCT04782895) ;\n* Subject has abnormal coagulation function (such as coagulation factor deficiency, coagulopathy, platelet abnormalities) or coagulation disorders;\n* Medical, psychological, social conditions, occupation or other factors, which considered by the investigator that may influence the conduct of the clinical study.'}, 'identificationModule': {'nctId': 'NCT06197802', 'briefTitle': 'Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women', 'organization': {'class': 'OTHER', 'fullName': 'Xiamen University'}, 'officialTitle': 'An Observational Study to Compare Plateau Antibody Levels of a Recombinant (E.Coli) Human Papillomavirus Nonavalent (Type 6/11/16/18/31/33/45/52/58) Vaccine Versus Gardasil®9 in Healthy Females 18-26 Years of Age', 'orgStudyIdInfo': {'id': 'HPV-PRO-011-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) group', 'description': 'Subjects would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli)', 'interventionNames': ['Biological: Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)']}, {'label': 'Gardasil®9 group', 'description': 'Subjects would receive 3 doses of 270μg/0.5ml Gardasil®9', 'interventionNames': ['Biological: Gardasil®9']}], 'interventions': [{'name': 'Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)', 'type': 'BIOLOGICAL', 'description': 'Three doses administered intramuscularly at 0, 45 day and 6 month.', 'armGroupLabels': ['Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) group']}, {'name': 'Gardasil®9', 'type': 'BIOLOGICAL', 'description': 'Three doses administered intramuscularly at 0, 45 day and 6 month.', 'armGroupLabels': ['Gardasil®9 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Provincial Centre for Disease Control and Prevention', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Jun Zhang, master', 'role': 'STUDY_CHAIR', 'affiliation': 'Xiamen University'}, {'name': 'Feng-cai Zhu, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Provincial Centre for Disease Control and Prevention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiamen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xiamen Innovax Biotech Co., Ltd', 'class': 'INDUSTRY'}, {'name': 'Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jun Zhang', 'investigatorAffiliation': 'Xiamen University'}}}}