Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-01 @ 1:44 PM
Study NCT ID:
NCT06142461
Status:
WITHDRAWN
Last Update Posted:
2024-05-24
First Post:
2023-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068857', 'term': 'Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18'}], 'ancestors': [{'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D053918', 'term': 'Papillomavirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Open-label vaccination. Serology samples for immunogenicity assessment are blinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Change in landscape of HPV treatment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2023-11-16', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System', 'timeFrame': 'Day 0 through Day 210'}, {'measure': 'Immunogenicity of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System', 'timeFrame': '28 days following each vaccination'}, {'measure': 'Safety of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System', 'timeFrame': 'Day 0 through Day 210'}, {'measure': 'Immunogenicity of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System', 'timeFrame': '28 days following each vaccination'}], 'secondaryOutcomes': [{'measure': 'Non-inferior immunogenicity of intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System compared to full dose intramuscular administration of Gardasil using needle and syringe', 'timeFrame': '28 days following each vaccination'}, {'measure': 'Non-inferior immunogenicity of intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System compared to full dose intramuscular administration of Gardasil using needle and syringe', 'timeFrame': '28 days following each vaccination'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaccine Reaction']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the safety and immunogenicity of an HPV Vaccine (Gardasil) delivered by intramuscular needle-free injection and intradermal needle-free injection. The main question it aims to answer is:\n\n* Is intramuscular and intradermal needle-free injection of Gardasil safe?\n* Does intramuscular and intradermal needle-free vaccination with Gardasil illicit an immune response?\n\nParticipants will:\n\n* Receive Gardasil by intramuscular needle-free injection, intradermal needle-free injection, or needle and syringe injection.\n* Provide blood samples\n* Complete physical exams\n* Complete diaries'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '12 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female between the age of 12 years and 13 years, inclusive. (Female 7th grade junior high school students in Indonesia)\n* Clinically healthy, as established by medical history and physical examination before entering the study.\n* Not pregnant at the time of vaccination.\n* Able to provide informed consent and assent.\n* Able to comply with the study.\n\nExclusion Criteria:\n\n* Previous vaccination against HPV.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days prior to study enrollment, or planned use during the study period.\n* Administration of any vaccine within 30 days prior the study enrollment, or within 30 days of study vaccination visits.\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study enrollment, or planned use during the study period.\n* Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.\n* History of allergic disease, suspected allergy, or reactions likely to be exacerbated by any component of vaccine, including yeast.\n* History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, autoimmune disease. Participants with medically stable, well controlled autoimmune disease may be permitted.\n* Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.\n* Received immunoglobulins and/or blood product within 90 days preceding enrollment, or planned use during the study period.\n* Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature \\<37.5°C.\n* Any condition that may interfere with ability to comply with trial procedures, as assessed by the Investigator.'}, 'identificationModule': {'nctId': 'NCT06142461', 'briefTitle': 'Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System', 'organization': {'class': 'INDUSTRY', 'fullName': 'PharmaJet, Inc.'}, 'officialTitle': 'Safety and Immunogenicity of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System', 'orgStudyIdInfo': {'id': 'HPV-PJ-01'}, 'secondaryIdInfos': [{'id': '1R44CA261326-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R44CA261326-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: Intradermal needle-free injection', 'description': 'Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System.', 'interventionNames': ['Drug: Gardasil', 'Device: PharmaJet Tropis® Needle-Free Injection System']}, {'type': 'EXPERIMENTAL', 'label': '2: Intramuscular needle-free injection', 'description': 'Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System', 'interventionNames': ['Drug: Gardasil', 'Device: PharmaJet Stratis® Needle-Free Injection System']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3: Needle and syringe', 'description': 'Full dose (0.5 mL injection) intramuscular administration of Gardasil® using needle and syringe', 'interventionNames': ['Drug: Gardasil']}], 'interventions': [{'name': 'Gardasil', 'type': 'DRUG', 'otherNames': ['Gardasil PFS, 0.5mL'], 'description': 'Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume', 'armGroupLabels': ['3: Needle and syringe']}, {'name': 'Gardasil', 'type': 'DRUG', 'otherNames': ['Gardasil vial, 0.5mL'], 'description': 'Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume', 'armGroupLabels': ['2: Intramuscular needle-free injection']}, {'name': 'Gardasil', 'type': 'DRUG', 'otherNames': ['Gardasil vial, 0.2mL'], 'description': 'Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume', 'armGroupLabels': ['1: Intradermal needle-free injection']}, {'name': 'PharmaJet Stratis® Needle-Free Injection System', 'type': 'DEVICE', 'otherNames': ['Stratis'], 'description': '0.5mL dose injection', 'armGroupLabels': ['2: Intramuscular needle-free injection']}, {'name': 'PharmaJet Tropis® Needle-Free Injection System', 'type': 'DEVICE', 'otherNames': ['Tropis'], 'description': '0.1mL dose injection', 'armGroupLabels': ['1: Intradermal needle-free injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bandung', 'country': 'Indonesia', 'facility': 'Universitas Padjadjaran', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PharmaJet, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}