Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-01 @ 2:28 AM
Study NCT ID:
NCT00768833
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
2008-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Nasopharyngeal Carriage in Healthy Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-20', 'studyFirstSubmitDate': '2008-10-07', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and frequency of S. pneumonia positive serotypes', 'timeFrame': '57 months'}], 'secondaryOutcomes': [{'measure': 'Changes in number and frequency of S. pneumonia positive children at different ages over time', 'timeFrame': '57 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['S.pneumoniae healthy subjects', 'Healthy subjects'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0887X1-4453&StudyName=Study%20Evaluating%20the%20Nasopharyngeal%20Carriage%20in%20Healthy%20Children', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the prevalence of pneumococcal stereotypes in the nasopharynx of healthy children and to describe the changes of nasopharyngeal carriage at different ages over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMain inclusion criteria:\n\n* Age at enrolment 3 to 4 month Main\n\nExclusion Criteria:\n\n* Malformation or injury of the nasopharynx\n* Known or suspected immunodeficiency\n* Relevant immunosuppression\n* Use of antibiotics up to 10 days prior to study inclusion'}, 'identificationModule': {'nctId': 'NCT00768833', 'acronym': 'Carriage', 'briefTitle': 'Study Evaluating the Nasopharyngeal Carriage in Healthy Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Nasopharyngeal Carriage in Children After Introduction of General Pneumococcal Immunization in Germany', 'orgStudyIdInfo': {'id': '0887X1-4453'}}, 'contactsLocationsModule': {'locations': [{'zip': '63069', 'city': 'Offenbach', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.10061, 'lon': 8.76647}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}