Ding Xi Shi

Researchers are comparing the immune response and safety of a single dose of the inactivated poliovirus vaccine sIPV in healthy adolescents and adults aged 7 to 50 years with the standard three-dose pentavalent vaccine DTaP-IPV-Hib given to infants aged 3 months. This Phase IV, open-label study will include 180 participants divided into three groups 60 adolescents, 60 adults, and 60 infants. The study aims to evaluate how well these vaccines stimulate immunity against poliovirus and other components. Participants aged 7 to 50 years will receive one intramuscular dose of sIPV on Day 0, while infants will receive three doses of the pentavalent vaccine at 3, 4, and 5 months of age. Blood samples will be collected before vaccination and 30 days after the last vaccine dose to measure antibody levels. The study will also monitor for any adverse events immediately after vaccination and for up to 30 days post-vaccination, including serious adverse events and pregnancy occurrences in fertile participants. Throughout the study, researchers will collect blood samples and observe participants for side effects using diary cards and follow-up contacts. Immunogenicity will be assessed by measuring antibody responses against poliovirus and other vaccine components. Safety will be closely monitored during and after vaccination. The total participation duration varies by group but includes multiple visits for vaccination, blood collection, and safety evaluations. This study is sponsored by Sinovac Biotech Co., Ltd and runs until May 2026.