nctId: NCT06331156 id: 218485 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 overallStatus: RECRUITING date: 2024-03-22 date: 2024-11-19 date: 2024-11-19 date: 2024-03-26 date: 2024-04-24 name: GlaxoSmithKline class: INDUSTRY 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. conditions: Gastroenteritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: HRV PCV-free name: IPV measure: Percentage of participants with seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing antibody (Ab) measure: Anti-poliovirus types 1, 2 and 3 neutralizing Ab geometric mean titers (GMTs) measure: Percentage of participants with anti-poliovirus types 1, 2 and 3 neutralizing Ab titers >=1:8 and >=1:64 measure: Percentage of participants with seroconversion for anti-rotavirus (RV) immunoglobulin A (IgA) Ab measure: Anti-RV IgA Ab geometric mean concentrations (GMCs) measure: Percentage of participants with anti-RV IgA Ab concentrations >= 90 U/mL measure: Percentage of participants reporting solicited systemic events measure: Percentage of participants reporting unsolicited adverse events (AEs) measure: Percentage of participants reporting serious adverse events (SAEs) sex: ALL minimumAge: 6 Weeks maximumAge: 10 Weeks stdAges: CHILD facility: GSK Investigational Site status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xuecheng Liu role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 facility: GSK Investigational Site status: RECRUITING city: Guang'an state: Sichuan zip: 638300 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xuecheng Liu role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site status: RECRUITING city: Neijiang state: Sichuan zip: 641200 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Yulin Jing role: PRINCIPAL_INVESTIGATOR lat: 29.58354 lon: 105.06216 facility: GSK Investigational Site status: RECRUITING city: Wenshan state: Yunnan zip: 663300 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xiaoqiang Liu role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site status: RECRUITING city: Wenshan zip: 663100 country: China name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Xiaoqing Liu role: PRINCIPAL_INVESTIGATOR hasResults: False