Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06824194
Status:
RECRUITING
Last Update Posted:
2025-10-28
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'France', 'Germany', 'Italy']}, 'interventionBrowseModule': {'meshes': [{'id': 'C492457', 'term': 'RIX4414 vaccine'}, {'id': 'C492535', 'term': 'RotaTeq'}, {'id': 'C000617220', 'term': 'Vaxelis'}, {'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022542', 'term': 'Measles-Mumps-Rubella Vaccine'}, {'id': 'D022362', 'term': 'Hepatitis A Vaccines'}], 'ancestors': [{'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D008458', 'term': 'Measles Vaccine'}, {'id': 'D009108', 'term': 'Mumps Vaccine'}, {'id': 'D012411', 'term': 'Rubella Vaccine'}, {'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Modified double-blind\n\n* Blinding for vaccine group assignment: participants and participant's parent(s) / legally acceptable representative(s) (LARs), outcome assessors, Investigators, laboratory personnel, and Sponsor study staff\n* No blinding for vaccine group assignment: those preparing and administering the study interventions"}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2320}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-05-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of any immediate adverse events (AEs)', 'timeFrame': 'Within 30 minutes after each vaccination', 'description': 'Number of participants experiencing solicited and unsolicited immediate AEs'}, {'measure': 'Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection', 'timeFrame': 'Through 7 days after each vaccine injection', 'description': 'Number of participants experiencing solicited injection site and systemic reactions'}, {'measure': 'Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection', 'timeFrame': 'Through 30 days after each vaccine injection', 'description': 'Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs'}, {'measure': 'Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)', 'timeFrame': 'Throughout the study (through 6 months post-last vaccine injection), approximately 19 months', 'description': 'Number of participants experiencing SAEs'}, {'measure': 'Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)', 'timeFrame': 'Throughout the study (through 6 months post-last vaccine injection), approximately 19 months', 'description': 'Number of participants experiencing AESIs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Immunization']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=26405&tenant=MT_SNY_9011', 'label': 'PSK05 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days).\n\nThe study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given as per local recommendations.\n\nThere will be 6 study visits:\n\nVisit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '89 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 42 to 89 days on the day of inclusion\n* Participants who are healthy as determined by medical evaluation including medical history and physical examination\n* Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable as assessed by the investigator\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy\n* History of microbiologically confirmed Streptococcus pneumoniae infection or disease\n* Any contraindication to the routine pediatric vaccine being administered in the study\n* History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy\n* Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances\n* Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legal acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion\n* Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \\[≥ 100.4°F\\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided\n* Receipt of any non-US Food and Drug Administration (FDA) approved vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any non-US FDA approved vaccine in the 4 weeks following the study intervention administration, including monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations.\n* Receipt of any Bacillus of Calmette and Guerin (BCG) vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period\n* Previous vaccination against S. pneumoniae\n* Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus\n* Receipt of more than 1 dose of hepatitis B vaccine\n* Receipt of immune globulins, blood or blood-derived products since birth\n* Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure\n\nNote: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT06824194', 'briefTitle': 'Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2 Arm Study to Investigate the Safety of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers', 'orgStudyIdInfo': {'id': 'PSK05'}, 'secondaryIdInfos': [{'id': 'U1111-1295-5983', 'type': 'OTHER', 'domain': 'WHO ICTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: PCV21', 'description': 'Participants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA', 'interventionNames': ['Biological: PCV21 vaccine', 'Biological: M-M-R II vaccine', 'Biological: Rotarix', 'Biological: RotaTeq', 'Biological: Vaxelis vaccine', 'Biological: Varivax', 'Biological: Priorix', 'Biological: VAQTA', 'Biological: Havrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: 20vPCV', 'description': 'Participants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA', 'interventionNames': ['Biological: Prevnar 20 vaccine', 'Biological: M-M-R II vaccine', 'Biological: Rotarix', 'Biological: RotaTeq', 'Biological: Vaxelis vaccine', 'Biological: Varivax', 'Biological: Priorix', 'Biological: VAQTA', 'Biological: Havrix']}], 'interventions': [{'name': 'PCV21 vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['515'], 'description': 'Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular', 'armGroupLabels': ['Group 1: PCV21']}, {'name': 'Prevnar 20 vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Prevnar20™'], 'description': 'Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular', 'armGroupLabels': ['Group 2: 20vPCV']}, {'name': 'M-M-R II vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['M-M-R™ II'], 'description': 'Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: 20vPCV']}, {'name': 'Rotarix', 'type': 'BIOLOGICAL', 'otherNames': ['Rotarix™'], 'description': 'Pharmaceutical form:Solution-Route of administration:Oral', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: 20vPCV']}, {'name': 'RotaTeq', 'type': 'BIOLOGICAL', 'otherNames': ['RotaTeq™'], 'description': 'Pharmaceutical form:Solution-Route of administration:Oral', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: 20vPCV']}, {'name': 'Vaxelis vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Vaxelis™'], 'description': 'Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: 20vPCV']}, {'name': 'Varivax', 'type': 'BIOLOGICAL', 'otherNames': ['Varivax™'], 'description': 'Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: 20vPCV']}, {'name': 'Priorix', 'type': 'BIOLOGICAL', 'otherNames': ['Priorix™'], 'description': 'Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: 20vPCV']}, {'name': 'VAQTA', 'type': 'BIOLOGICAL', 'otherNames': ['VAQTA™'], 'description': 'Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: 20vPCV']}, {'name': 'Havrix', 'type': 'BIOLOGICAL', 'otherNames': ['Havrix™'], 'description': 'Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular', 'armGroupLabels': ['Group 1: PCV21', 'Group 2: 20vPCV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35976', 'city': 'Guntersville', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Lakeview Clinical Research- Site Number : 8400054', 'geoPoint': {'lat': 34.35823, 'lon': -86.29446}}, {'zip': '35121', 'city': 'Oneonta', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Midway Medical Clinic Biopharma Informatic- Site Number : 8400091', 'geoPoint': {'lat': 33.94815, 'lon': -86.47276}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': "The Children's Clinic- Site Number : 8400079", 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72120', 'city': 'Sherwood', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Helios CR, Inc. - Little Rock- Site Number : 8400090', 'geoPoint': {'lat': 34.81509, 'lon': -92.22432}}, {'zip': '92831', 'city': 'Fullerton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Helping Hands Healthcare Group - Fullerton- Site Number : 8400063', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90250', 'city': 'Hawthorne', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advanced Investigative Medicine- Site Number : 8400055', 'geoPoint': {'lat': 33.9164, 'lon': -118.35257}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Matrix Clinical Research - Los Angeles- Site Number : 8400026', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93637', 'city': 'Madera', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Madera Family Medical Group- Site Number : 8400011', 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '91356-4173', 'city': 'Sherman Oaks', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Integrated Clinical Research LLC- Site Number : 8400027', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '33122', 'city': 'Doral', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'D&H Doral Research Center- Site Number : 8400095', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33172', 'city': 'Doral', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Nextlevel Research Center- Site Number : 8400065', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33549', 'city': 'Lutz', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'PAS RESEARCH-Lutz- Site Number : 8400103', 'geoPoint': {'lat': 28.15112, 'lon': -82.46148}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Abba Medical Research- Site Number : 8400064', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33169', 'city': 'North Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'D&H National Research Center- Site Number : 8400085', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '33029', 'city': 'Pembroke Pines', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Alfa Medical Research LLC- Site Number : 8400111', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '30310', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Morehouse School of Medicine - Atlanta- Site Number : 8400093', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'CenExel - iResearch - Savannah- Site Number : 8400057', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '83221', 'city': 'Blackfoot', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Bingham Memorial Hospital - Blackfoot- Site Number : 8400114', 'geoPoint': {'lat': 43.19047, 'lon': -112.34498}}, {'zip': '83221', 'city': 'Blackfoot', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Elite Clinical Trials - Blackfoot- Site Number : 8400017', 'geoPoint': {'lat': 43.19047, 'lon': -112.34498}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Prime- Site Number : 8400022', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Chicago Medical Center- Site Number : 8400062', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61265', 'city': 'Moline', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MidValley Research - Moline- Site Number : 8400096', 'geoPoint': {'lat': 41.5067, 'lon': -90.51513}}, {'zip': '46617', 'city': 'South Bend', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'South Bend Clinic - Main Campus- Site Number : 8400023', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '50265', 'city': 'West Des Moines', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Integrated Clinical Trial Services- Site Number : 8400059', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Kentucky Pediatric Research- Site Number : 8400014', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Kentucky Chandler Medical Center- Site Number : 8400034', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Novak Center For Children's Health- Site Number : 8400073", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40243', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Bluegrass Clinical Research - Louisville - Blankenbaker Parkway- Site Number : 8400056', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70508', 'city': 'Lafayette', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Velocity Clinical Research - Lafayette- Site Number : 8400046', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '70125', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Works INC- Site Number : 8400035', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21045', 'city': 'Columbia', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Pediatric Center- Site Number : 8400075', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '21702', 'city': 'Frederick', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Pediatric Center of Frederick- Site Number : 8400074', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '20910', 'city': 'Silver Spring', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Virgo Carter Pediatrics- Site Number : 8400001', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}, {'zip': '48126', 'city': 'Dearborn', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vida Clinical Studies LLC- Site Number : 8400094', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '55402', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Institute - Minneapolis- Site Number : 8400002', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '68504', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Midwest Children's Health Research Institute - Lincoln - Salt Creek Circle- Site Number : 8400019", 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68505', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Midwest Children's Health Research Institute- Site Number : 8400016", 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Be Well Clinical Studies - Lincoln- Site Number : 8400031', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Midwest Childrens Health Research Institute- Site Number : 8400021', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68522', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Midwest Children's Health Research Institute - Lincoln - West A Street- Site Number : 8400045", 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89014', 'city': 'Henderson', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'PAS Research- Site Number : 8400033', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SUNY Downstate Medical Center- Site Number : 8400039', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '13057', 'city': 'East Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Child Health Care Associates - East Syracuse- Site Number : 8400005', 'geoPoint': {'lat': 43.06534, 'lon': -76.07853}}, {'zip': '10460', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'PAS Research-Bronx- Site Number : 8400104', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advantage Clinical Trials- Site Number : 8400030', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Atrium Health - Myers Park- Site Number : 8400080', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Atrium Health - STRIVE Vaccine Research Clinic- Site Number : 8400060', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28721', 'city': 'Clyde', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Haywood Pediatric and Adolescent Medicine Group- Site Number : 8400051', 'geoPoint': {'lat': 35.53344, 'lon': -82.91069}}, {'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United 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{'lat': 38.41273, 'lon': 27.13838}}, {'zip': '61080', 'city': 'Trabzon', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Investigational Site Number : 7920010', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'centralContacts': [{'name': 'Trial Transparency email recommended (Toll free for US & Canada)', 'role': 'CONTACT', 'email': 'contact-us@sanofi.com', 'phone': '800-633-1610', 'phoneExt': 'option 6'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. 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