protocolSection identificationModule nctId: NCT06331156, orgStudyIdInfo id: 218485, secondaryIdInfos id: 2022-000708-36, type: EUDRACT_NUMBER, briefTitle: A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-11-19, completionDateStruct date: 2024-11-19, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment., conditionsModule conditions: Gastroenteritis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: HRV PCV-free, interventions name: IPV, outcomesModule primaryOutcomes measure: Percentage of participants with seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing antibody (Ab), secondaryOutcomes measure: Anti-poliovirus types 1, 2 and 3 neutralizing Ab geometric mean titers (GMTs), secondaryOutcomes measure: Percentage of participants with anti-poliovirus types 1, 2 and 3 neutralizing Ab titers >=1:8 and >=1:64, secondaryOutcomes measure: Percentage of participants with seroconversion for anti-rotavirus (RV) immunoglobulin A (IgA) Ab, secondaryOutcomes measure: Anti-RV IgA Ab geometric mean concentrations (GMCs), secondaryOutcomes measure: Percentage of participants with anti-RV IgA Ab concentrations >= 90 U/mL, secondaryOutcomes measure: Percentage of participants reporting solicited systemic events, secondaryOutcomes measure: Percentage of participants reporting unsolicited adverse events (AEs), secondaryOutcomes measure: Percentage of participants reporting serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 6 Weeks, maximumAge: 10 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: GSK Investigational Site, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Xuecheng Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, locations facility: GSK Investigational Site, status: RECRUITING, city: Guang'an, state: Sichuan, zip: 638300, country: China, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Xuecheng Liu, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, status: RECRUITING, city: Neijiang, state: Sichuan, zip: 641200, country: China, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Yulin Jing, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.58354, lon: 105.06216, locations facility: GSK Investigational Site, status: RECRUITING, city: Wenshan, state: Yunnan, zip: 663300, country: China, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Xiaoqiang Liu, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, status: RECRUITING, city: Wenshan, zip: 663100, country: China, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Xiaoqing Liu, role: PRINCIPAL_INVESTIGATOR, hasResults: False