Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT00387569
Status:
COMPLETED
Last Update Posted:
2008-05-08
First Post:
2006-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-06', 'studyFirstSubmitDate': '2006-10-11', 'studyFirstSubmitQcDate': '2006-10-12', 'lastUpdatePostDateStruct': {'date': '2008-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months', 'timeFrame': 'Vaccinations at 0,1,6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Toddlers', 'Vaccine', 'Safety'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Aged 18- to 36-months\n* Healthy male or female subjects\n\nExclusion Criteria\n\n* Prior vaccination with a serogroup B meningococcal vaccine\n* Prior history of any invasive meningococcal disease'}, 'identificationModule': {'nctId': 'NCT00387569', 'briefTitle': 'Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 µg, 60 µg, and 200 µg of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years', 'orgStudyIdInfo': {'id': '6108A1-502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Experimental (20ug); Active Comparator/Placebo', 'interventionNames': ['Biological: MnB vaccine rLP8026']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Experimental (60ug); Active Comparator/Placebo', 'interventionNames': ['Biological: MnB vaccine rLP8026']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Experimental (200ug); Active Comparator/Placebo', 'interventionNames': ['Biological: MnB vaccine rLP8026']}], 'interventions': [{'name': 'MnB vaccine rLP8026', 'type': 'BIOLOGICAL', 'description': 'MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)', 'armGroupLabels': ['Cohort 1']}, {'name': 'MnB vaccine rLP8026', 'type': 'BIOLOGICAL', 'description': 'MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)', 'armGroupLabels': ['Cohort 2']}, {'name': 'MnB vaccine rLP8026', 'type': 'BIOLOGICAL', 'description': 'MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)', 'armGroupLabels': ['Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6840', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Australia, medinfo@wyeth.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Wyeth (Registry Contact: Clinical Trial Registry Specialist)', 'oldOrganization': 'Wyeth'}}}}