Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-08 @ 10:57 AM
Study NCT ID:
NCT06638333
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-13
First Post:
2024-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Serotype Distribution of Streptococcus Pneumoniae in Healthy Vietnamese Children From 6 Months to 5 Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Nasopharyngeal sample will be put in retention without analysis of human DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2024-10-09', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of pneumococcal carriage in the nasopharynx in children from 6 months to 5 years old in the Vietnamese community', 'timeFrame': 'Day 0 after recruitment', 'description': 'Pneumococcal prevalence in children by age group, sex and geographical area'}, {'measure': 'Serotype distribution of pneumococcal strains in Vietnamese children from 6 months to 5 years old in the community', 'timeFrame': 'Day 0 after recruitment', 'description': 'The number of carrier individuals by serotype will be determined for age group, sex and geographical area'}], 'secondaryOutcomes': [{'measure': 'Risk factors associated with pneumococcal carriage', 'timeFrame': 'Day 0 after recruitment', 'description': 'Gender, age, urban vs rural setting, environmental, lifestyle factors and other factors will be analyzed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Streptococcus Pneumonia']}, 'descriptionModule': {'briefSummary': "This observational study is designed as a cross-sectional survey of children from 6 months and 5 years old who visit the Vietnam Vaccination Center (VNVC) system in Hanoi, Danang and Ho Chi Minh City for vaccination services.\n\nAfter getting the informed consent form from a parent/guardian for their child(s) to participate in the study, nasopharyngeal swab sample will be taken. His/her guardian will be interviewed face-to-face with information related to epidemiological characteristics, nutritional status, child's birth history, hospitalization history, vaccination history, recent antibiotic usage, breastfeeding time, and environmental and lifestyle factors.\n\nThe goal is to document the burden and risk factors of pneumococcal infections in the community of healthy Vietnamese children. The main questions it aims to answer are:\n\n* What is the prevalence of pneumococcus in healthy children?\n* What is the distribution of pneumococcus serotypes in the community of healthy Vietnamese children?\n* What are risk factors of pneumococcus infection in the community of healthy Vietnamese children?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children from 6 months and 5 years old who visit the Vietnam Vaccination Center (VNVC) system in Hanoi, Danang and Ho Chi Minh city for vaccination services', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between 6 months and 5 years\n\nExclusion Criteria:\n\n* Children with chronic diseases (including immunologic diseases, neoplastic disorders, renal, cardiac, hepatic, or hematologic diseases, broncho dysplasia, Down syndrome, chronic otitis media with effusion)\n* Children with acute/chronic upper or lower respiratory tract infection\n* Children have used antibiotics within 1 week prior to entering the study'}, 'identificationModule': {'nctId': 'NCT06638333', 'briefTitle': 'Prevalence and Serotype Distribution of Streptococcus Pneumoniae in Healthy Vietnamese Children From 6 Months to 5 Years Old', 'organization': {'class': 'OTHER', 'fullName': 'Tam Anh Research Institute'}, 'officialTitle': 'Prevalence and Serotype Distribution of Streptococcus Pneumoniae in Healthy Vietnamese Children From 6 Months to 5 Years Old', 'orgStudyIdInfo': {'id': 'TA0002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children between 6 months and 5 years'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Da Nang', 'country': 'Vietnam', 'facility': 'VNVC Da Nang', 'geoPoint': {'lat': 16.06778, 'lon': 108.22083}}, {'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'VNVC Icon4 Cau Giay', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}, {'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'VNVC Tan Phu', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tam Anh Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}