protocolSection identificationModule nctId: NCT06284915, orgStudyIdInfo id: MEQ00089, secondaryIdInfos id: MEQ00089, type: OTHER, domain: Sanofi Identifier, secondaryIdInfos id: 2023-508177-85, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1280-6981, type: REGISTRY, domain: ICTRP, briefTitle: Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2025-03-10, completionDateStruct date: 2025-03-11, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sanofi Pasteur, a Sanofi Company, class: INDUSTRY, descriptionModule briefSummary: This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants., conditionsModule conditions: Meningococcal Immunisation, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: The study will be performed in a modified double-blind fashion:* Investigators and study staff who conduct the safety assessment, and the participants parent/ legally acceptable representative will not know which study intervention is administered* Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study intervention is administered, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 840, type: ESTIMATED, armsInterventionsModule interventions name: MenACYW conjugate vaccine, interventions name: MenACYW conjugate vaccine, outcomesModule primaryOutcomes measure: Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, Y and W, secondaryOutcomes measure: hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W, secondaryOutcomes measure: hSBA antibody titers against meningococcal serogroups A, C, W, and Y, secondaryOutcomes measure: hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W, secondaryOutcomes measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA, secondaryOutcomes measure: hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse, secondaryOutcomes measure: Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y, secondaryOutcomes measure: rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W, secondaryOutcomes measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA, secondaryOutcomes measure: rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse, secondaryOutcomes measure: Number of participants with immediate adverse events (AEs), secondaryOutcomes measure: Number of participants with solicited injection site reactions or systemic reactions, secondaryOutcomes measure: Number of participants with unsolicited AEs, secondaryOutcomes measure: Number of participants with serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 14 Months, stdAges: CHILD, contactsLocationsModule locations facility: Investigational Site Number: 2030001, status: RECRUITING, city: Ceske Budejovice, country: Czechia, geoPoint lat: 48.97447, lon: 14.47434, locations facility: Investigational Site Number: 2030005, status: RECRUITING, city: Prague, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Investigational Site Number: 2080004, status: RECRUITING, city: Aarhus, country: Denmark, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Investigational Site Number: 2460006, status: RECRUITING, city: Jaarvenpa, country: Finland, locations facility: Investigational Site Number: 2460007, status: RECRUITING, city: Oulu, country: Finland, geoPoint lat: 65.01236, lon: 25.46816, locations facility: Investigational Site Number: 2460004, status: RECRUITING, city: Tampere, country: Finland, geoPoint lat: 61.49911, lon: 23.78712, locations facility: Investigational Site Number: 2460012, status: RECRUITING, city: Turku, country: Finland, geoPoint lat: 60.45148, lon: 22.26869, locations facility: Investigational Site Number: 2760007, status: RECRUITING, city: Erfurt, country: Germany, geoPoint lat: 50.9787, lon: 11.03283, locations facility: Investigational Site Number: 2760001, status: RECRUITING, city: Moenchengladbach, country: Germany, geoPoint lat: 51.18539, lon: 6.44172, locations facility: Investigational Site Number: 2760005, status: RECRUITING, city: Schoenau Am Koenigssee, country: Germany, locations facility: Investigational Site Number: 6160017, status: RECRUITING, city: Bydgoszcz, country: Poland, geoPoint lat: 53.1235, lon: 18.00762, locations facility: Investigational Site Number: 6160015, status: RECRUITING, city: Krakow, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Investigational Site Number: 6160021, status: RECRUITING, city: Krakow, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Investigational Site Number: 6160016, status: RECRUITING, city: Leczna, country: Poland, geoPoint lat: 51.30121, lon: 22.88135, locations facility: Investigational Site Number: 6160012, status: RECRUITING, city: Lubon, country: Poland, geoPoint lat: 52.34705, lon: 16.89267, locations facility: Investigational Site Number: 6160007, status: RECRUITING, city: Torun, country: Poland, geoPoint lat: 53.01375, lon: 18.59814, locations facility: Investigational Site Number: 6160014, status: RECRUITING, city: Trzebnica, country: Poland, geoPoint lat: 51.31076, lon: 17.06331, locations facility: Investigational Site Number: 6160010, status: RECRUITING, city: Wroclav, country: Poland, locations facility: Investigational Site Number: 6420005, status: RECRUITING, city: Calarasi, country: Romania, geoPoint lat: 44.2051, lon: 27.31356, hasResults: False