Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-22 @ 10:47 AM
Study NCT ID:
NCT00508950
Status:
COMPLETED
Last Update Posted:
2016-08-17
First Post:
2007-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Serum Collected From Healthy Adults For Development of Pneumococcal Opsonophagocytic Assay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-16', 'studyFirstSubmitDate': '2007-07-27', 'studyFirstSubmitQcDate': '2007-07-27', 'lastUpdatePostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify potential serum donors and obtain unit volumes of blood from these donors for use in pneumococcal opsonophagocytic assay development.', 'timeFrame': '8 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vaccines', 'Pneumococcal Conjugate Vaccine', 'Adult'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6115A1-1000&StudyName=Study%20Evaluating%20Serum%20Collected%20From%20Healthy%20Adults%20For%20Development%20of%20Pneumococcal%20Opsonophagocytic%20Assay', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study will identify healthy adults who have been vaccinated against pneumococcus, and collect blood for the purpose of developing laboratory assays.', 'detailedDescription': 'Collect serum with antibody levels capable of killing pneumococcal bacteria from healthy prevaccinated adults to develop OPA assays for the 13 serotypes in 13-valent pneumococcal conjugate vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults 18-70 years of age\n* Must have received 23vPS pneumococcal vaccine\n\nExclusion Criteria:\n\n* Bleeding diathesis\n* Pregnancy\n* Chronic disease which could be worsened by donating blood\n* Receipt of blood, blood products or immune globulin within six months'}, 'identificationModule': {'nctId': 'NCT00508950', 'briefTitle': 'Study Evaluating Serum Collected From Healthy Adults For Development of Pneumococcal Opsonophagocytic Assay', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Pneumococcal Opsonophagocytic Assay Development.', 'orgStudyIdInfo': {'id': '6115A1-1000'}, 'secondaryIdInfos': [{'id': 'B1851075', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All subjects', 'description': 'All subjects', 'interventionNames': ['Procedure: Large volume blood draw']}], 'interventions': [{'name': 'Large volume blood draw', 'type': 'PROCEDURE', 'description': 'Large volume blood draw', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07094', 'city': 'Secaucus', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Frontage Clinical Services Inc.', 'geoPoint': {'lat': 40.78955, 'lon': -74.05653}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}