NCT06132789

A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10-60 Years

A Randomized, Single-arm, Phase Ⅰ Clinical Trial to Evaluate the Safety of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried Vaccinated With Different Immunization Schedule in People Aged 10-60 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ab&B Bio-tech Co., Ltd.JS · Academic / Other
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The safety of different immunization procedures of rabies vaccine (human diploid cells) was investigated by successive design of different age groups. The two vaccination procedures were carried out successively according to the age of the subjects from the oldest to the youngest. The first 40 subjects aged 18-60 were randomly assigned to the Essen experimental group and the Zagreb experimental group in a 1:1 ratio, all of whom received the experimental vaccine. After the observation of the third dose of vaccine for at least 7 days, the preliminary safety assessment was conducted. If the incidence of grade 3 or higher adverse events associated with the experimental vaccination did not exceed 15%, and no vaccination-related death or life-threatening serious adverse events occurred, 40 subjects aged 10-17 years old were enrolled, and 40 subjects aged 10-17 years old were randomly assigned to the Essen and Zagreb trials in a 1:1 ratio. Conduct safety studies. Safety study: All adverse events that occurred within 30 minutes, 0-7 days, and 0-30 days after each dose were collected, as well as all serious adverse events that occurred within 6 months after the first dose. Blood and urine samples were collected before the first dose and 3 days after the first dose, and blood routine, blood biochemical and urine routine tests were performed for safety assessment.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried	This vaccine（1.0ml） is produced by Ab\&b Biotechnology Co., Ltd.JS. Subjects will receive the Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried vaccinated by intramuscular injection.

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-08-16
• Completion: 2024-08-16
• First posted: 2023-11-15
• Last updated: 2026-01-02

Locations

1 site across 1 country: China