Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-29 @ 1:53 AM
Study NCT ID:
NCT00323050
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2005-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006192', 'term': 'Haemophilus Infections'}], 'ancestors': [{'id': 'D016871', 'term': 'Pasteurellaceae 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': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 468}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2005-08-26', 'studyFirstSubmitQcDate': '2006-05-08', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage (%) of subjects with anti-PRP antibody concentrations (conc) ≥1µg/ml and % of subjects with SBA-MenC titers ≥ 128 one month post vaccination.'}], 'secondaryOutcomes': [{'measure': 'Pre & 1M post vacc, S+/SP & conc/titer: SBA-MenC, anti-PSC,-PRP,-T & anti-PRP ≥ 1,-PSC ≥ 2, SBA-MenC ≥ 128'}, {'measure': 'Pre vacc, S+/SP & conc/titer: anti-D,-PT,-FHA,-PRN,-HBs, -polio 1,2,3'}, {'measure': 'Loc, gen sympt: D 0-3, unsol sympt: D 0-30 post vacc.'}, {'measure': 'SAEs for whole study'}]}, 'conditionsModule': {'conditions': ['Neisseria Meningitidis', 'Haemophilus Influenzae Type b']}, 'referencesModule': {'availIpds': [{'id': '102547', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '102547', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '102547', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '102547', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '102547', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '102547', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.', 'detailedDescription': 'The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa / Infanrix IPV/Hib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Months', 'minimumAge': '13 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy male or female between, and including, 13 and 14 months of age\n* Having participated in the primary vaccination study 217744/097.\n\nExclusion criteria:\n\n* Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection\n* A family history of congenital or hereditary immunodeficiency\n* History of any neurologic disorders or seizures'}, 'identificationModule': {'nctId': 'NCT00323050', 'briefTitle': 'Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Evaluate Immunogenicity,Safety & Reactogenicity of a Booster Dose of Hib-MenC Conjugate Vaccine When Given to Healthy Subjects Aged 13-14 Months Who Were Primed With 3 Doses of Hib-MenC vs a Booster Dose of Infanrix Hexa Given to Subjects Primed With 3 Doses of Infanrix Hexa and Meningitec', 'orgStudyIdInfo': {'id': '102547'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Haemophilus influenzae type b- and meningococcal (vaccine)', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28922', 'city': 'Alcorcón', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'zip': '4009', 'city': 'Almeira', 'country': 'Spain', 'facility': 'GSK Investigational Site'}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08950', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48013', 'city': 'Basurto/Bilbao', 'country': 'Spain', 'facility': 'GSK Investigational Site'}, {'zip': '09005', 'city': 'Burgos', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '28905', 'city': 'Getafe', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28047', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '28935', 'city': 'Móstoles/Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site'}, {'zip': '07014', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '47010', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Vélez-Málaga', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.78107, 'lon': -4.10266}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}