Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-28 @ 12:39 AM
Study NCT ID:
NCT01414504
Status:
COMPLETED
Last Update Posted:
2012-09-17
First Post:
2011-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pneumococcal Conjugate Vaccine Followup
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-08-13', 'releaseDate': '2014-07-24'}], 'estimatedResultsFirstSubmitDate': '2014-07-24'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069443', 'term': 'Heptavalent Pneumococcal Conjugate Vaccine'}, {'id': 'D011237', 'term': 'Predictive Value of Tests'}], 'ancestors': [{'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D012680', 'term': 'Sensitivity and Specificity'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-14', 'studyFirstSubmitDate': '2011-08-02', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2012-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure serotype-specific antibody persistence in children aged 3-5 years after vaccination with 23vPPV at 9 months of age and compared to unvaccinated controls.', 'timeFrame': '2yrs', 'description': 'Children who were previously vaccinated with Pneumovax (23vPPV) at 9 months will be followed up at age 3-5 years of age. They will be given a challenge dose of Pneumovax (0.1mL) and followed up 1 months later. Age matched controls identified from each villages will also be recruited and given a challenge dose of Pneumovax. Serotype-specific antibodies will be measure pre- and post-challenge dose to determine anitbody levels.'}], 'secondaryOutcomes': [{'measure': 'Measure the number of circulating serotype-specific memory B-cells pre- & post- booster immunisation', 'timeFrame': '2yrs'}, {'measure': 'Measure nasopharyngeal pneumococcal serotype-specific carriage rates pre- and post- 23vPPV challenge dose', 'timeFrame': '2yrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pneumococcal,', 'pneumococcal polysaccharide vaccine,', 'challenge dose,', 'hyporesponsiveness,', 'Papua New Guinea'], 'conditions': ['Immune Tolerance']}, 'referencesModule': {'references': [{'pmid': '29028802', 'type': 'DERIVED', 'citation': 'van den Biggelaar AHJ, Richmond PC, Fuery A, Anderson D, Opa C, Saleu G, Lai M, Francis JP, Alpers MP, Pomat WS, Lehmann D. Pneumococcal responses are similar in Papua New Guinean children aged 3-5 years vaccinated in infancy with pneumococcal polysaccharide vaccine with or without prior pneumococcal conjugate vaccine, or without pneumococcal vaccination. PLoS One. 2017 Oct 13;12(10):e0185877. doi: 10.1371/journal.pone.0185877. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Recently, controversy has emerged regarding the role of the 23vPPV in infants due to potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated protective efficacy against acute lower respiratory tract infection, the investigators feel it is a matter of urgency to determine if 23vPPV administration provides elevated antibody concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV in infants.\n\nFollowing consent and eligibility assessment, a baseline blood sample and nose swab will be taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab will be collected 28 days later. The investigators will also collect data on incidence of ALRI in all study participants by medical record review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PNG Infants aged 3 to 5 yrs of age who participated in previous PNG Neonatal PCV study and received PPV between 9 and 12 months of age, or age- and sex-matched controls who live in the same villages or urban area\n* Informed parental/guardian consent\n\nExclusion Criteria:\n\n* Known HIV infection or other immunosuppressive condition or treatment.\n* Prior receipt of 2 doses of pneumococcal polysaccharide vaccine'}, 'identificationModule': {'nctId': 'NCT01414504', 'acronym': 'PCVFU', 'briefTitle': 'Pneumococcal Conjugate Vaccine Followup', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Papua New Guinea Institute of Medical Research'}, 'officialTitle': 'Pneumococcal Conjugate Vaccine Followup: Investigation of Serotype-specific Antibody Persistence and B Cell Memory at Age 3-5 Years Following 23valent Pneumococcal Polysaccharide Vaccine at Age 9 Months in PNG Children Previously Primed With 7valent Pneumococcal Conjugate Vaccine', 'orgStudyIdInfo': {'id': 'PCVFU927'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neonatal PCV + PPV 9 months', 'description': 'Group 1: Children receiving 7VPCV at 0-1-2 months of age and PPV at 9 months of age', 'interventionNames': ['Biological: Prevenar + PPV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infant PCV + PPV at 9 months', 'description': 'Group 2: Children receiving 7VPCV at 1-2-3 months of age and PPV at 9 months of age', 'interventionNames': ['Biological: Infant PCV (Prevenar) + PPV at 9 months']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No PCV + PPV at 9 months', 'description': 'Group 3: Children who only received PPV at 9 months of age', 'interventionNames': ['Biological: No Prevenar + PPV at 9 months']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Group 4: Children who have not received any previous pneumococcal vaccine', 'interventionNames': ['Biological: Control']}], 'interventions': [{'name': 'Prevenar + PPV', 'type': 'BIOLOGICAL', 'description': '0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs', 'armGroupLabels': ['Neonatal PCV + PPV 9 months']}, {'name': 'Infant PCV (Prevenar) + PPV at 9 months', 'type': 'BIOLOGICAL', 'otherNames': ['Prevenar', 'Pneumovax23'], 'description': '0.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs', 'armGroupLabels': ['Infant PCV + PPV at 9 months']}, {'name': 'No Prevenar + PPV at 9 months', 'type': 'BIOLOGICAL', 'description': 'no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs', 'armGroupLabels': ['No PCV + PPV at 9 months']}, {'name': 'Control', 'type': 'BIOLOGICAL', 'description': 'control, 0.1mL Pneumovax at 3-5yrs', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '441', 'city': 'Goroka', 'state': 'Eastern Highlands Province', 'country': 'Papua New Guinea', 'facility': 'PNG Institute of Medical Research', 'geoPoint': {'lat': -6.085, 'lon': 145.38667}}], 'overallOfficials': [{'name': 'Peter C Richmond, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Paediatrics and Child Health, University of Western Australia'}, {'name': 'Deborah Lehmann, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Telethon Institute for Child Health Research'}, {'name': 'William S Pomat, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Papua New Guinea Institute of Medical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'William Pomat', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The University of Western Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Research Fellow', 'investigatorFullName': 'William Pomat', 'investigatorAffiliation': 'Papua New Guinea Institute of Medical Research'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-07-24', 'type': 'RELEASE'}, {'date': '2014-08-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'William Pomat, Senior Research Fellow, Papua New Guinea Institute of Medical Research'}}}}