Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT00964769
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2009-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Evaluation Indexes for Antibody Production in Sera After Immunization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}], 'ancestors': [{'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-24', 'studyFirstSubmitDate': '2009-08-24', 'studyFirstSubmitQcDate': '2009-08-24', 'lastUpdatePostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly.', 'timeFrame': '1 month after vaccination'}], 'secondaryOutcomes': [{'measure': 'Evaluate the immune response to the pneumococcal polysaccharide vaccine with two methods (ELISA and Opsonophagocytic Killing Assay)', 'timeFrame': '1 month after vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pneumococcal Vaccine', 'Aged'], 'conditions': ['Aged']}, 'referencesModule': {'references': [{'pmid': '20219110', 'type': 'DERIVED', 'citation': 'Lee H, Nahm MH, Kim KH. The effect of age on the response to the pneumococcal polysaccharide vaccine. BMC Infect Dis. 2010 Mar 10;10:60. doi: 10.1186/1471-2334-10-60.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA, pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after immunization (pneumococcal PS vaccine) in children, adults and elderly.', 'detailedDescription': 'To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly, samples from children, young adults and elderly were obtained before and one month after vaccination. The quantitative and qualitative response to the vaccine were measured by the ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14, 18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elderly subjects over the age 65 years who had not received pneumococcal vaccination\n* adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination)\n* children subjects over the age of 2 years with no previous history of pneumococcal vaccination\n\nExclusion Criteria:\n\n* immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine'}, 'identificationModule': {'nctId': 'NCT00964769', 'briefTitle': 'Study of Evaluation Indexes for Antibody Production in Sera After Immunization', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'A Study of Evaluation Indexes for Antibody Production in Sera After Immunization', 'orgStudyIdInfo': {'id': 'EU-KF-05092341'}, 'secondaryIdInfos': [{'id': '05092KFDA341'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pneumococcal polysaccharide vaccine', 'description': 'The immunogenic response to the pneumococcal polysaccharide vaccine was compared between children, adults and elderly.', 'interventionNames': ['Biological: pneumococcal polysaccharide vaccine']}], 'interventions': [{'name': 'pneumococcal polysaccharide vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumo23®'], 'description': 'single intramuscular injection of 0.5 ml Pneumo23® (Sanofi-Aventis, Lyon France)', 'armGroupLabels': ['Pneumococcal polysaccharide vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-125', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Dongdaemun Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung-Hyo Kim, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ewha Womans University Dongdaemun Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kyung-Hyo Kim', 'oldOrganization': 'Ewha Womans Univrsity Hospital'}}}}