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RECRUITING
NCT07021703
PHASE1

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

Sponsor: Ningbo Rongan Biological Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The Phase 1 clinical trial of the freeze-dried human rabies vaccine (human diploid cells) will be conducted on participants aged 10 to 60. This study will design a single-arm, randomized, open-access trial with different immunization schedules (5-dose schedule and 2-1-1 schedule) to evaluate the safety and tolerability of the vaccine in participants aged 10 to 60

Official title: A Open-label, Randomized Study to Evaluate the Safety and Tolerability of Freeze-dried Human Rabies Vaccine (Human Diploid Cells) Administered to Participants With Different Immunization Schedules

Key Details

Gender

All

Age Range

10 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-05-23

Completion Date

2025-12-31

Last Updated

2025-06-15

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Freeze-dried Human Rabies Vaccine(Human Diploid Cell), Essen

This vaccine is produced by Ningbo Rongyu Biological Pharmaceutical Co., Ltd.. Participants will receive AIM2301 by intramuscular injection. Receive on the day 0, 3, 7, 14 and 28, a total of 5 doses

BIOLOGICAL

Freeze-dried Human Rabies Vaccine(Human Diploid Cell),Zagreb

This vaccine is produced by Ningbo Rongyu Biological Pharmaceutical Co., Ltd.. Participants will receive AIM2301 by intramuscular injection. Receive 2 doses on day 0, 1 dose on day 7 and day 21, a total of 4 doses.

Locations (1)

Henan Provincial Center for Disease Control and Prevention

Zhengzhou, Henan, China