Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT06128733
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2023-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C570015', 'term': '4CMenB vaccine'}, {'id': 'C000729870', 'term': 'MenB-FHbp vaccine'}, {'id': 'D022401', 'term': 'Meningococcal Vaccines'}], 'ancestors': [{'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Modified double-blind: in order to maintain the blind, a placebo injection will be given and blood sample will be collected from all participants at each visit'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with immediate adverse events (AEs)', 'timeFrame': 'Within 30 minutes after each vaccination', 'description': 'Unsolicited systemic AEs that occur within 30 minutes after vaccination'}, {'measure': 'Number of participants with solicited injection site reactions or systemic reactions', 'timeFrame': 'Within 7 days after each vaccination', 'description': 'Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF'}, {'measure': 'Number of participants with unsolicited AEs', 'timeFrame': 'Within 30 days after each vaccination', 'description': 'Non-serious AEs other than solicited reactions'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'From baseline up to 12 months', 'description': 'SAEs (including adverse events of special interest \\[AESIs\\]) reported throughout the study'}, {'measure': 'Number of participants with medically attended adverse events (MAAEs)', 'timeFrame': 'From baseline up to 12 months', 'description': "An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or Emergency Department"}, {'measure': 'Number of participants with out-of-range biological test results', 'timeFrame': 'Before each vaccination up to 7 days after primary vaccination visits in the sentinel cohorts (the first 5 participants enrolled in each vaccine group) of each age group'}, {'measure': 'hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second dose in adolescent participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 7)', 'description': 'Seroresponse defined as post-second vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \\< 1:4 or post-second vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than or equal to the lower limit of quantification (LLOQ)'}, {'measure': 'hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the second dose in adolescent participants', 'timeFrame': 'Day 211 (for Group 1 to 7)', 'description': 'hSBA titers ≥ 1:8'}, {'measure': 'Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose in adolescent participants', 'timeFrame': 'Day 01 (pre-dose) and Day 31 Day 211 (for Group 1 to 7)', 'description': 'Geometric mean titers'}, {'measure': 'Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y in adolescent participants', 'timeFrame': 'Day 01 (pre-dose) Day 211 (for Group 1 to 7)'}, {'measure': 'hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after second dose in adolescent participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 7)', 'description': 'Seroresponse defined as a 4-fold increase in hSBA titers'}, {'measure': 'Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second dose in adolescent participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 7)', 'description': 'hSBA titers ≥ 1:4 for reference MenB strains'}, {'measure': 'Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second dose in adolescent participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 7)', 'description': 'hSBA titers ≥ 1:8 for reference MenB strains'}, {'measure': 'Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-second dose in adolescent participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 7)', 'description': 'Geometric mean titers for the reference MenB strains'}, {'measure': 'Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adolescent participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 7)'}], 'secondaryOutcomes': [{'measure': 'hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse at each timepoint', 'timeFrame': 'D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)', 'description': 'Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers \\< 1:4 or post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with pre-dose 1 vaccination titers more than the lower limit of quantification (LLOQ)'}, {'measure': 'hSBA meningococcal serogroups A, C, W, and Y antibody titers at each timepoint', 'timeFrame': 'D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)', 'description': 'hSBA titers ≥ 1:8 post-vaccination'}, {'measure': 'Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y at each timepoint', 'timeFrame': 'D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)', 'description': 'Geometric mean titers'}, {'measure': 'Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y at each timepoint', 'timeFrame': 'D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)'}, {'measure': 'hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse at each timepoint', 'timeFrame': 'D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)', 'description': 'Seroresponse defined as a 4-fold increase in hSBA titers'}, {'measure': 'Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 at each timepoint', 'timeFrame': 'D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)', 'description': 'hSBA titers ≥ 1:4 for reference MenB strains'}, {'measure': 'Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 at each timepoint', 'timeFrame': 'D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)', 'description': 'hSBA titers ≥ 1:8 reference MenB strains'}, {'measure': 'Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint', 'timeFrame': 'D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)', 'description': 'Geometric mean titers for reference MenB strains'}, {'measure': 'Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ for reference MenB strains for each timepoint', 'timeFrame': 'D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)'}, {'measure': 'hSBA meningococcal serogroup B (reference and additional MenB strains) vaccine seroresponse pre-dose 1 and 1 month post-second and third dose in adolescent participants', 'timeFrame': 'Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)', 'description': 'Seroresponse defined as a 4-fold increase in hSBA titers from D01 to post-vaccination for reference and additional MenB strains'}, {'measure': 'Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second and third dose in adolescent participants', 'timeFrame': 'Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)', 'description': 'hSBA titers ≥ 1:4 for reference and additional MenB strains'}, {'measure': 'Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second and third dose in adolescent participants', 'timeFrame': 'Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)', 'description': 'hSBA titers ≥ 1:8 for reference and additional MenB strains'}, {'measure': 'Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference and additional MenB strains) pre-dose 1 and 1 month post-second and third dose in adolescent participants', 'timeFrame': 'Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)', 'description': 'Geometric mean titers for reference and additional MenB strains'}, {'measure': 'Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ reference and additional MenB strains in adolescent participants', 'timeFrame': 'Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)'}, {'measure': 'hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse 1 month after the third dose in adult participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 6)', 'description': 'Seroresponse defined as post-third vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \\< 1:4 or post-third vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than the lower limit of quantification (LLOQ)'}, {'measure': 'hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the third dose in adult participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 6)'}, {'measure': 'Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the third dose in adult participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 6)'}, {'measure': 'Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y in adult participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 6)'}, {'measure': 'hSBA meningococcal serogroup B (reference MenB strains) seroresponse pre-dose and 1 month after third dose in adult participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 6)'}, {'measure': 'Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-third dose in adult participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 6)'}, {'measure': 'Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-third dose in adult participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 6)'}, {'measure': 'Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-third dose in adult participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 6)'}, {'measure': 'Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adult participants', 'timeFrame': 'Day 01 (pre-dose) and Day 211 (for Group 1 to 6)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningococcal Immunisation', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents.\n\nThe study duration will be up to 12 months for all participants.', 'detailedDescription': 'The study duration will be approximately 12 months for all participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria: - Aged 18 to 25 years or 10 to 17 years on the day of inclusion\n\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator.\n* Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine at least 4 years prior to study enrollment Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:\n* Known or suspected congenital or acquired immunodeficiency\n* History of any Neisseria meningitidis infection\n* At high risk for meningococcal infection during the study\n* Individuals with active tuberculosis\n* History of Guillain-Barré syndrome\n* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT06128733', 'briefTitle': 'Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity Study to Assess Pentavalent Meningococcal ABCYW Vaccine Formulations in Adults (18 to 25 Years of Age) and Adolescents (10 to 17 Years of Age).', 'orgStudyIdInfo': {'id': 'VAN00010'}, 'secondaryIdInfos': [{'id': 'U1111-1272-6824', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': '2023-000924-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: MenPenta Formulation 1', 'description': 'Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo', 'interventionNames': ['Biological: Pentavalent Meningococcal ABCYW vaccine', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: MenPenta Formulation 2', 'description': 'Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo', 'interventionNames': ['Biological: Pentavalent Meningococcal ABCYW vaccine', 'Biological: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3: Bexsero® + Menveo®', 'description': 'Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine', 'interventionNames': ['Biological: Meningococcal group B vaccine', 'Biological: MenACYW conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4: Trumenba® + Menveo®', 'description': 'Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine', 'interventionNames': ['Biological: Meningococcal group B vaccine', 'Biological: MenACYW conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 5: MenQuadfi®', 'description': 'Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo', 'interventionNames': ['Biological: MenACYW conjugate vaccine', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6: Sanofi MenB', 'description': 'Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo', 'interventionNames': ['Biological: Meningococcal group B vaccine', 'Biological: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 7: PENBRAYA', 'description': 'Participants (ACWY naive and primed adolescents) will receive injections of PENBRAYA vaccine and placebo', 'interventionNames': ['Biological: MenABCYW conjugate vaccine']}], 'interventions': [{'name': 'Pentavalent Meningococcal ABCYW vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['MenPenta'], 'description': 'Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)', 'armGroupLabels': ['Group 1: MenPenta Formulation 1', 'Group 2: MenPenta Formulation 2']}, {'name': 'MenACYW conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['MenQuadFi®'], 'description': 'Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)', 'armGroupLabels': ['Group 5: MenQuadfi®']}, {'name': 'Meningococcal group B vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Bexsero®'], 'description': 'Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)', 'armGroupLabels': ['Group 3: Bexsero® + Menveo®']}, {'name': 'Meningococcal group B vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Trumenba®'], 'description': 'Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)', 'armGroupLabels': ['Group 4: Trumenba® + Menveo®']}, {'name': 'Meningococcal group B vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Sanofi MenB'], 'description': 'Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)', 'armGroupLabels': ['Group 6: Sanofi MenB']}, {'name': 'MenACYW conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Menveo®'], 'description': 'Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM)', 'armGroupLabels': ['Group 3: Bexsero® + Menveo®', 'Group 4: Trumenba® + Menveo®']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)', 'armGroupLabels': ['Group 1: MenPenta Formulation 1', 'Group 2: MenPenta Formulation 2', 'Group 5: MenQuadfi®', 'Group 6: Sanofi MenB']}, {'name': 'MenABCYW conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['PENBRAYATM'], 'description': 'Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)', 'armGroupLabels': ['Group 7: PENBRAYA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Accel Research Site - Birmingham Clinical Research Unit- Site Number : 8400080', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35976-2206', 'city': 'Guntersville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Lakeview Clinical Research Site Number : 8400029', 'geoPoint': {'lat': 34.35823, 'lon': -86.29446}}, {'zip': '85281', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research- Phoenix- Site Number : 8400056', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '72432', 'city': 'Harrisburg', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Harrisburg Family Medical Center Site Number : 8400070', 'geoPoint': {'lat': 35.56425, 'lon': -90.71678}}, {'zip': '92806', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Smart Cures Clinical Research Site Number : 8400072', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91303', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'Hope Clinical Research, LLC- Site Number : 8400001', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '95628', 'city': 'Fair Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Apex Research Group Site Number : 8400071', 'geoPoint': {'lat': 38.64463, 'lon': -121.27217}}, {'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Velocity Clinical Research-Washington DC Site Number : 8400102', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32720-0834', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Accel Clinical Research-Deland Clinical Research Unit- Site Number : 8400081', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'SIMEDHealth, LLC- Site Number : 8400045', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33777', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Accel Research Sites-St. Petersburg-Largo- Site Number : 8400082', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '33166', 'city': 'Medley', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Research Organization Site Number : 8400086', 'geoPoint': {'lat': 25.84065, 'lon': -80.32644}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Life Arc Research-Miami Site Number : 8400094', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Charisma Medical and Research center Site Number : 8400097', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32829', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Accel Research - Nona Pediatric Center Site Number : 8400079', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Ormond Beach Clinical Research- Site Number : 8400073', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Harbor Dermatology- Site Number : 8400030', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'PAS Research Site Number : 8400032', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'VICIS Clinical Research-Tampa Site Number : 8400065', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Leavitt Clinical Research-Idaho Falls- Site Number : 8400075', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Snake River Research, PLLC- Site Number : 8400100', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '61614', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'AES Peoria- Site Number : 8400090', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '47712', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'AMR Evansville Site Number : 8400062', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': 'AMR - Newton- Site Number : 8400104', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '40004', 'city': 'Bardstown', 'state': 'Kentucky', 'country': 'United States', 'facility': '~Kentucky Pediatics / Adult Research- Site Number : 8400009', 'geoPoint': {'lat': 37.80923, 'lon': -85.4669}}, {'zip': '40517', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Michael W. 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Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}