Phase I Study to Assess Safety and Early Immune Response of Diphtheria-Tetanus-acellular Pertussis Vaccine in Children Aged 2 Months to 6 Years

What this Trial Is About

Researchers are conducting a randomized, single-blind, active-controlled phase I clinical trial to evaluate the safety and early immune response of a combined Diphtheria-Tetanus-acellular Pertussis DTacP vaccine in children aged 2 months to 6 years. The study aims to assess adverse events shortly after vaccination and up to 12 months later, as well as measure antibody levels to various components of the vaccine. The trial includes infants, toddlers, and children, with careful monitoring of immune response and safety outcomes. The trial is divided into three stages by age groups children aged 6 years, toddlers aged 18-24 months, and infants aged 2 to 3 months. Participants are randomly assigned to receive either the DTacP vaccine or other vaccines such as DT, DTaP, or Pentaxim in different dosing schedules and injection sites. Children and toddlers receive a single injection on Day 0, while infants receive three doses over 2 to 4 months following specific immunization schedules. Safety reviews occur after each stage to decide progression. Participants will be monitored closely for adverse events through diaries, phone calls, and face-to-face visits for up to 12 months after vaccination. Blood, urine, and other lab tests will be performed before and after vaccination to assess safety and immune responses. Antibody levels against diphtheria, tetanus, pertussis, and poliovirus will be measured before vaccination, 30 days after, and for infants, again at 12 months. The study duration varies by group but may last up to 16 months for infants.

Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine