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Clinical Trial of Freeze-dried Human Rabies Vaccine (Human Diploid Cells)
Sponsor: Ningbo Rongan Biological Pharmaceutical Co., Ltd.
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
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
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
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
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
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