Phase III Study Evaluating Safety and Immune Response of a Cell-free Diphtheria and Tetanus Vaccine in Infants Aged 2 to 3 Months

What this Trial Is About

Researchers are evaluating the immune response and safety of a new combined vaccine that protects against diphtheria, tetanus, and whooping cough in infants and young children aged 2 to 3 months. This Phase III clinical trial aims to compare the effects of an adsorption-free version of this vaccine with other combined vaccines to understand how well it protects against these diseases. The importance of this research lies in preventing these serious infections in early childhood. The study involves three groups receiving different vaccine formulations DTacP, DTaP, and DTacP-IPVHib. Each group will get injections at 2 months, 4 months, 6 months, 18 to 24 months, and some at 6 years of age, with doses of 0.5 ml administered by injection. The DTacP-IPVHib group receives doses up to 18 months of age. These vaccinations are given to see how each vaccine performs over time in building immunity. Participants will be monitored for immune response 30 days after the primary immunization and after booster doses. Safety will also be tracked up to 12 months after completing the full vaccination series. Throughout the study, infants and young children will have vaccination visits, health assessments, and follow-ups to ensure data is collected on how their bodies respond to the vaccines and to monitor for any side effects. The total participation spans several years with multiple immunization points and safety checks.

Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial