Phase 1 Study to Assess Safety and Tolerability of Freeze-Dried Human Rabies Vaccine in Participants Aged 10 to 60 Using Two Different Immunization Schedules

What this Trial Is About

Researchers are conducting a Phase 1 clinical trial to study a freeze-dried human rabies vaccine made from human diploid cells. This trial aims to evaluate the safety and tolerability of this vaccine in participants aged 10 to 60 years. The study is designed as a single-arm, randomized, and open-label trial, enrolling 60 participants split evenly between younger 10-17 years and adult 18-60 years age groups. The trial compares two different immunization schedules to assess their effects. Participants in the adult group are randomly assigned to receive either a 5-dose schedule with vaccine doses on days 0, 3, 7, 14, and 28, or a 2-1-1 schedule with doses on day 0 two doses, day 7, and day 21. Safety is closely monitored for seven days after the first dose in the adult group. After confirming safety, the younger group follows the same randomization and dosing schedules. Vaccinations are given by intramuscular injection. Throughout the study, researchers collect information on any adverse events occurring from the first dose through 30 days after completing the full vaccination. Serious adverse events and pregnancy-related outcomes are monitored for six months after vaccination completion. Safety assessments include monitoring reactions within 30 minutes and 7 days after each dose, laboratory tests on the third day after the first dose, and ongoing observations for serious events. The total duration of participation includes vaccination and follow-up safety monitoring.

A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried