Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-28 @ 8:55 AM
Study NCT ID:
NCT04965350
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'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': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose', 'timeFrame': 'At Month 7'}, {'measure': 'Percentage of participants who seroconvert to HPV-16 and/or HPV-18 at one month post 3rd dose', 'timeFrame': 'At Month 7', 'description': 'Seroconversion was defined as: For initially seronegative subjects \\[antibody titer below (\\<) 1:40 prior to vaccination\\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:40 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (TEAE) during 30 days after each dose', 'timeFrame': '0~30 days after each vaccination'}, {'measure': 'Incidence of solicited adverse events (AEs) after vaccination', 'timeFrame': '0~7 days after each vaccination'}, {'measure': 'Incidence of unsolicited AEs after vaccination', 'timeFrame': '0~30 days after each vaccination'}, {'measure': 'Incidence of serious adverse events (SAEs)', 'timeFrame': 'Month 0 to Month 7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HPV Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot scale.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '9 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 9-30 healthy female able to provide legal identification.\n* Written informed consent had to be obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent had to be obtained from a parent or legal guardian of the subject and, in addition, the subject had to sign and personally date a written informed assent).\n* Women of child-bearing age(WOCBA): Subject had to have a negative urine pregnancy test, no plan to be pregnant in 7 months, and agree to use adequate contraceptive precautions during study period.\n\nExclusion Criteria:\n\n* Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial.\n* History of abnormal cervical screen test result (ASC-US or worse) or history of genital warts.\n* History of severe allergic reaction that required medical intervention.\n* History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.\n* Pregnant or breastfeeding, or within 6 weeks after the end of pregnancy.\n* Fever prior to vaccination (auxiliary temperature ≥37.3 °C).\n* Hypertension (physical examination systolic blood pressure 140mmHg and or diastolic blood pressure 90mmHg.\n* Received live attenuated vaccine within 15 days before vaccination or subunit or inactivated vaccine within 7 days.\n* Received immunoglobulin and/or blood product 3 months prior to the first vaccination.\n* Acute diseases or acute stage of the chronic diseases within 3 days preceding the vaccination.\n* According to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial.'}, 'identificationModule': {'nctId': 'NCT04965350', 'briefTitle': 'Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Zerun Biotechnology Co.,Ltd'}, 'officialTitle': 'A Phase III, Randomized, Double-blind Study to Assess the Consistency of the Immunogenicity of Three Consecutive Production Lots of Bivalent HPV Vaccine in Healthy Female Subjects Aged 9 - 30 Years and to Demonstrate Non-inferiority of the Candidate HPV Vaccine Manufactured at Commercial Scale Compared With a Pilot Scale', 'orgStudyIdInfo': {'id': '311-HPV-1005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2vHPV Consistency Lot 1', 'interventionNames': ['Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)']}, {'type': 'EXPERIMENTAL', 'label': '2vHPV Consistency Lot 2', 'interventionNames': ['Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)']}, {'type': 'EXPERIMENTAL', 'label': '2vHPV Consistency Lot 3', 'interventionNames': ['Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2vHPV Pilot Scale Lot', 'interventionNames': ['Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)']}], 'interventions': [{'name': 'Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)', 'type': 'BIOLOGICAL', 'description': 'sterile solution for intramuscular injection', 'armGroupLabels': ['2vHPV Consistency Lot 1', '2vHPV Consistency Lot 2', '2vHPV Consistency Lot 3', '2vHPV Pilot Scale Lot']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mianyang', 'state': 'Sichuan', 'country': 'China', 'facility': 'Mianyang Center for Disease Control and Prevention', 'geoPoint': {'lat': 31.46784, 'lon': 104.68168}}], 'overallOfficials': [{'name': 'Ting Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sichuan Center for Disease Control and Prevention'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zerun Biotechnology Co.,Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Yuxi Zerun Biotechnology Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}