Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-25 @ 7:57 PM
Study NCT ID:
NCT00581620
Status:
COMPLETED
Last Update Posted:
2007-12-27
First Post:
2007-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Prevenar Immunogenicity in High Risk Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-21', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'To evaluate tolerability of Prevenar* in that population.', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pneumococcus conjugated vaccine'], 'conditions': ['Vaccines, Pneumococcal Conjugate Vaccine']}, 'descriptionModule': {'briefSummary': 'To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.', 'detailedDescription': 'This study will require 24 months to be completed. Each child will participate for a period of time according to age of the 1st dose of vaccination: infants up to 6 months of age will be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months; children between 12 months up to 9 years of age will be evaluate for 2 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between 2 months to 9 years old.\n* Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease\n* No history of seizures'}, 'identificationModule': {'nctId': 'NCT00581620', 'briefTitle': 'Study Evaluating Prevenar Immunogenicity in High Risk Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.', 'orgStudyIdInfo': {'id': '0887X-100974'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'G1', 'description': 'G1: HIV+', 'interventionNames': ['Biological: pneumococcus conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'G2', 'description': 'G2: Sicle Cell disease', 'interventionNames': ['Biological: pneumococcus conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'G3', 'description': 'G3: neprotic symdrome', 'interventionNames': ['Biological: pneumococcus conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'G4', 'description': 'G4: Chronic pulmonary disease', 'interventionNames': ['Biological: pneumococcus conjugate vaccine']}], 'interventions': [{'name': 'pneumococcus conjugate vaccine', 'type': 'BIOLOGICAL', 'description': 'Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.', 'armGroupLabels': ['G1', 'G2', 'G3', 'G4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, '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'}}}}