Ding Xi Shi

Researchers are conducting a Phase IV clinical study to compare the immune response and safety of one dose of the inactivated poliovirus vaccine (Sabin strain, sIPV) in healthy adolescents and adults aged 7 to 50 years with that of three doses of the pentavalent vaccine (DTaP-IPV-Hib) in healthy infants aged 3 months. The study is focused on measuring antibody responses to three poliovirus serotypes and monitoring safety events following vaccination. The study will enroll 180 participants divided into three groups: 60 adolescents aged 7-17 years, 60 adults aged 18-50 years, and 60 infants aged 3 months. Adolescents and adults will receive a single intramuscular dose of sIPV on Day 0, while infants will receive three doses of DTaP-IPV-Hib at 3, 4, and 5 months of age. Blood samples will be collected before vaccination and 30 days after the last vaccination to assess antibody levels. Participants will be observed for immediate adverse events for 30 minutes after vaccination, and diary cards will be used to record any adverse events from Day 0 to Day 30. Serious adverse events will be collected from the first vaccination until 30 days after the final dose. Fertile participants and their partners will be followed for pregnancy events during and after the study. The main outcomes focus on the seroconversion rates of antibodies against poliovirus serotypes 30 days post-vaccination.