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NCT07028801
PHASE3

Clinical Trial of Freeze-dried Human Rabies Vaccine (Human Diploid Cells)

Sponsor: Ningbo Rongan Biological Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The Phase 3 clinical trial of freeze-dried human rabies vaccine (human diploid cells) adopted a randomized, blinded, parallel control,non-inferiority design,and administered vaccines to participants aged 10 to 60 years with different immunization schedules (5-dose schedule group, two simple 4-dose schedule groups, and 2-1-1 schedule group) to evaluate the immunogenicity and safety of the vaccine.

Official title: A Randomized, Blinded, Parallel Controlled, Non-inferiority Design Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Human Diploid Cells) Administered to Participants Aged 10 to 60 Years With Different Immunization Schedules

Key Details

Gender

All

Age Range

10 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2025-07-31

Completion Date

2026-03-31

Last Updated

2025-06-19

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Freeze-dried human rabies vaccine (human diploid cells)

This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 5 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 1 dose on day 0, 3, 7, 14 and 28, total 5 doses

BIOLOGICAL

Freeze-dried human rabies vaccine (human diploid cells)

This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 4 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 1 dose on day 0, 3, 7 and 14, total 4 doses

BIOLOGICAL

Freeze-dried human rabies vaccine (human diploid cells)

This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 4 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 1 dose on day 0, 3, 7 and 28, total 4 doses

BIOLOGICAL

Freeze-dried human rabies vaccine (human diploid cells)

This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 4 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 2 dose on day 0, 1 dose on day 7 and 21, total 4 doses

BIOLOGICAL

Freeze-dried human rabies vaccine (human diploid cells)

This vaccine is produced by Chengdu Kanghua Biological Products Co., LTD Participants will be administered 5 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection Receive 1 dose on day 0, 3, 7, 14and 28, total 5 doses

Locations (1)

Henan Provincial Center for Disease Control and Prevention

Zhengzhou, Henan, China