Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-06 @ 7:13 PM
Study NCT ID:
NCT01782066
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2013-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-finding and Safety of 2 Intradermal MEN-ACYW135-conjugate Vaccines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022401', 'term': 'Meningococcal Vaccines'}], 'ancestors': [{'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-28', 'studyFirstSubmitDate': '2013-01-30', 'studyFirstSubmitQcDate': '2013-01-31', 'lastUpdatePostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroprotection rate against meningococcal serogroups ACYW135 (anti-meningococcal antibody titre at baseline and 28 days after vaccination)', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Local and systemic adverse events (subject log and investigator inspection).', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Meningococcal Disease']}, 'referencesModule': {'references': [{'pmid': '29778515', 'type': 'DERIVED', 'citation': 'Jonker EFF, van Ravenhorst MB, Berbers GAM, Visser LG. Safety and immunogenicity of fractional dose intradermal injection of two quadrivalent conjugated meningococcal vaccines. Vaccine. 2018 Jun 18;36(26):3727-3732. doi: 10.1016/j.vaccine.2018.05.064. Epub 2018 May 16.'}]}, 'descriptionModule': {'briefSummary': 'Invasive meningococcal disease is a worldwide problem with serious repercussions for those affected. Vaccination is recognized as the best way to combat it. The cost of vaccination is prohibitive in many low-resource settings at home and abroad. By harnessing the special immunologic properties of the skin, a dose reduction may be achieved by intradermal administration of the vaccine. The cost savings associated with dose reduction will increase availability of the vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMeningococcal C naive subjects are required to fulfill all of the following criteria:\n\n* Age ≥ 30 years\n* Good health according to the investigator\n* Willingness and ability to adhere to the study regimen\n* Able to give informed consent\n\nMeningococcal C experienced subjects are required to fulfill all of the following criteria:\n\n* Age ≥ 18 years\n* Good health according to the investigator\n* Willingness and ability to adhere to the study regimen\n* Able to give informed consent\n\nExclusion Criteria:\n\nMeningococcal C naïve subjects should not have:\n\n* Known previous invasive meningococcal infection\n* Known or suspected previous vaccination against meningococcal disease\n* Known or suspected allergy against any of the vaccine components\n* Close contact in the last 60 days with a person known to be Neisseria positive\n* History of unusual or severe reactions to any previous vaccination\n* Family history of Guillain-Barré Syndrome\n* Known or suspected immune deficiency, either congenital or acquired\n* Administration of plasma or blood products less than three months prior to inclusion in the study\n* Pregnancy (breastfeeding is allowed)\n* Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)\n* Any infectious disease\n* Bleeding disorders or use of anticoagulants\n* Participation as a subject in another trial in the last 3 months\n\nMeningococcal C experienced subjects should not have:\n\n* Known or suspected allergy against any of the vaccine components\n* Known previous vaccination with a quadrivalent meningococcal vaccine (either conjugate or polysaccharide)\n* Close contact in the last 60 days with a person known to be Neisseria positive\n* History of unusual or severe reactions to any previous vaccination\n* Family history of Guillain-Barré Syndrome\n* Known or suspected immune deficiency, either congenital or acquired\n* Administration of plasma or blood products less than three months prior to inclusion in the study\n* Pregnancy (breastfeeding is allowed)\n* Fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant)\n* Any infectious disease\n* Bleeding disorders or use of anticoagulants\n* Participation as a subject in another trial in the last 3 months'}, 'identificationModule': {'nctId': 'NCT01782066', 'briefTitle': 'Dose-finding and Safety of 2 Intradermal MEN-ACYW135-conjugate Vaccines', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Dose Finding and Reactogenicity of Reduced-dose Intradermal Administration of Two Quadrivalent Meningococcal Conjugate Vaccines (Menveo® and Nimenrix®) in Healthy Adults (MENID-1).', 'orgStudyIdInfo': {'id': 'MENID-1'}, 'secondaryIdInfos': [{'id': '2012-003085-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Menveo, dose escalating', 'interventionNames': ['Biological: MEN-ACYW135 reduced-dose intradermal administration']}, {'type': 'EXPERIMENTAL', 'label': 'Nimenrix, dose escalating', 'interventionNames': ['Biological: MEN-ACYW135 reduced-dose intradermal administration']}], 'interventions': [{'name': 'MEN-ACYW135 reduced-dose intradermal administration', 'type': 'BIOLOGICAL', 'otherNames': ['Menveo', 'Nimenrix'], 'description': 'Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines.', 'armGroupLabels': ['Menveo, dose escalating', 'Nimenrix, dose escalating']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333ZA', 'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Leo Visser, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Internal Medicine, Senior Consultant Infectious Diseases', 'investigatorFullName': 'L.G. Visser, MD, PhD', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}