Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT01459432
Status:
COMPLETED
Last Update Posted:
2015-11-09
First Post:
2011-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Immunity Persistence After Adolescent MenC Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'lastUpdateSubmitDate': '2015-11-06', 'studyFirstSubmitDate': '2011-10-21', 'studyFirstSubmitQcDate': '2011-10-24', 'lastUpdatePostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with rSBA titre ≥1:8 (correlate of protection).', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Geometric mean titre (GMT) rSBA.', 'timeFrame': '4 months'}]}, 'conditionsModule': {'conditions': ['Antibody Persistance After Booster Dose of Men C Vaccine']}, 'referencesModule': {'references': [{'pmid': '23853000', 'type': 'DERIVED', 'citation': 'de Whalley PC, Snape MD, Plested E, Thompson B, Nuthall E, Omar O, Borrow R, Pollard AJ. Long-term seroprotection after an adolescent booster meningococcal serogroup C vaccination. Arch Dis Child. 2013 Sep;98(9):686-91. doi: 10.1136/archdischild-2013-303893. Epub 2013 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the duration of immunity after a booster dose of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does seroprotection persist beyond teenage years and into the early twenties? This is the age group which is most likely to carry the organism and to transmit it to other members of the population. If a booster dose of MenC vaccine given to adolescents does produce protective levels of antibody which persist into early adulthood, this would strengthen the case for such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a resurgence of the disease in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '23 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young adults, approximately 20 - 23 years old.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who completed clinical study M14P2E1\n* Participant who are willing to participate and who would be expected to comply with the requirements of the protocol\n* Participants who have given informed consent for participation in the study\n\nExclusion Criteria:\n\n* History of invasive meningococcal C disease (or any case of invasive meningococcal disease where the serotype was unknown)\n* Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection\n* Severe blood clotting disorders'}, 'identificationModule': {'nctId': 'NCT01459432', 'briefTitle': 'Understanding Immunity Persistence After Adolescent MenC Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'A Study to Evaluate the Persistence of Antibody Seven Years After a Booster Dose of Either a Glycoconjugate or a Polysaccharide Vaccine Against Serogroup C Neisseria Meningitidis Given to Adolescents', 'orgStudyIdInfo': {'id': 'OVG 2011/03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Follow-on blood sample from previous study', 'interventionNames': ['Other: Venepuncture and blood sample collection.']}], 'interventions': [{'name': 'Venepuncture and blood sample collection.', 'type': 'OTHER', 'description': 'Venepuncture and blood sample collection.', 'armGroupLabels': ['Follow-on blood sample from previous study']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 8NQ', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Vaccine Group', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}