Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT06177912
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 882}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with solicited injection-site adverse events (AEs)', 'timeFrame': 'Up to 5 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include pain/tenderness, redness/erythema, and swelling.'}, {'measure': 'Percentage of participants with solicited systemic AEs', 'timeFrame': 'Up to 5 days', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs include headache, muscle aches/myalgia, and tiredness/fatigue.'}, {'measure': 'Percentage of participants with vaccine-related serious adverse events (SAEs)', 'timeFrame': 'Up to approximately 6 months', 'description': 'A vaccine-related SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event.'}, {'measure': 'Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses', 'timeFrame': '30 days postvaccination', 'description': 'Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA)'}], 'secondaryOutcomes': [{'measure': 'Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) after vaccination', 'timeFrame': '30 days postvaccination', 'description': 'The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL)'}, {'measure': 'Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA.'}, {'measure': 'Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs GMTs', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs will be determined with MOPA.'}, {'measure': 'GMFR from baseline in serotype-specific IgG GMCs', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'The GMFR from baseline in GMCs for serotype-specific IgG antibodies will be determined using PnECL.'}, {'measure': 'Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs', 'timeFrame': 'Baseline (Day 1) and Day 30 postvaccination', 'description': 'The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs will be determined using PnECL.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26202&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a diagnosis and stable medical management (for at least 3 months) of one of the following risk conditions for pneumococcal disease: Diabetes mellitus, chronic compensated liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease.\n* Has completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) at least 8 weeks before study enrollment.\n\nExclusion Criteria:\n\n* Has previously received PPSV23 vaccine\n* Has a history of active hepatitis within 3 months before study vaccination\n* History of invasive pneumococcal disease within 3 years before study vaccination'}, 'identificationModule': {'nctId': 'NCT06177912', 'acronym': 'STRIDE-13', 'briefTitle': 'A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease', 'orgStudyIdInfo': {'id': 'V116-013'}, 'secondaryIdInfos': [{'id': 'V116-013', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'jRCT2031230559', 'type': 'REGISTRY', 'domain': 'jRCT'}, {'id': '2023-506236-32', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1293-4944', 'type': 'REGISTRY', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V116', 'description': 'Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1', 'interventionNames': ['Biological: V116']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PPSV23', 'description': 'Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.', 'interventionNames': ['Biological: PPSV23']}], 'interventions': [{'name': 'V116', 'type': 'BIOLOGICAL', 'otherNames': ['Pneumococcal 21-valent Conjugate Vaccine'], 'description': 'Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution', 'armGroupLabels': ['V116']}, {'name': 'PPSV23', 'type': 'BIOLOGICAL', 'otherNames': ['PNEUMOVAX™23'], 'description': 'Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution', 'armGroupLabels': ['PPSV23']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 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'United States', 'facility': 'University of South Florida-Department of Pediatrics ( Site 0110)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31210', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128)', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '83221', 'city': 'Blackfoot', 'state': 'Idaho', 'country': 'United States', 'facility': 'Bingham Memorial Hospital ( Site 0149)', 'geoPoint': {'lat': 43.19047, 'lon': -112.34498}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Clinical Research Prime ( Site 0105)', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '83440', 'city': 'Rexburg', 'state': 'Idaho', 'country': 'United States', 'facility': 'Clinical Research Prime Rexburg ( Site 0104)', 'geoPoint': {'lat': 43.82602, 'lon': -111.78969}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "University of Louisville, Norton Children's Research Institute ( Site 0148)", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70508', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Velocity Clinical Research, Lafayette ( Site 0103)', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '39503', 'city': 'Gulfport', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Velocity Clinical Research, Gulfport ( Site 0115)', 'geoPoint': {'lat': 30.36742, 'lon': -89.09282}}, {'zip': '68901', 'city': 'Hastings', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Velocity Clinical Research, Hastings ( Site 0114)', 'geoPoint': {'lat': 40.58612, 'lon': -98.38839}}, {'zip': '68504', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': "Midwest Children's Health Research Institute ( Site 0117)", 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68505', 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'Santiago', 'state': 'Region M. de Santiago', 'country': 'Chile', 'facility': 'Centro de Estudios Clínicos (ICIM, Facultad de Medicina Clínica Alemana Universidad del Desarrollo)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8330077', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'country': 'Chile', 'facility': 'Pontificia Universidad Catolica de Chile-Pediatric Infectious Diseases and Immunology ( Site 0209)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8380418', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'country': 'Chile', 'facility': 'Hospital Roberto del Río-Infectología Pediátrica ( Site 0200)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8880465', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'country': 'Chile', 'facility': 'Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0204)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '4781151', 'city': 'Temuco', 'state': 'Región de la Araucanía', 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