NCT06078423

A Clinical Trial of Freeze-dried Human Rabies Vaccine (MRC-5 Cells)

Randomized, Blind, Phase III Clinical Trial Comparing the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (MRC-5 Cells) With a 5-dose Program and a 4-dose (2-dose First-dose) Program

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,880 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Phase 1 and Phase 2

Detailed description

This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages. Phase 1: 40 adult subjects aged 18-60 were randomly assigned to receive the trial vaccine in a 1:1 ratio according to a 5-dose immunization program (0, 3, 7, 14, 28 days) or a 4-dose immunization program (0, 7, 21 days (2 doses for the first dose). The number of recipients for each immunization program was 20. All subjects in the adult group underwent a preliminary safety assessment 7 days after the first dose of vaccination (before the third dose of vaccine), but did not meet the suspension/termination criteria. A further 40 underage subjects aged 10-17 were enrolled in the same order as the adult group, and all subjects underwent a preliminary safety assessment 7 days after the full dose of vaccination. If they did not meet the suspension/termination criteria, they entered the second phase of the study. Phase 2: A total of 1800 subjects aged 10 to 60 years old were randomly assigned to three groups in a 1:1:1 ratio, namely the 5-dose experimental group (vaccinated with the 5-dose program), the 5-dose control group (vaccinated with the 5-dose program), and the 4-dose experimental group (vaccinated with the 4-dose program). All subjects collected blood samples before the first dose, 7 days after the first dose, 14 days after the first dose, and 14 days after the entire dose for immunogenicity evaluation; Subjects who meet the requirements for immune persistence observation in the plan shall collect blood samples 3 months after the full vaccination, and the experimental group subjects shall also collect blood samples 12 months after the full vaccination for immune persistence evaluation. Collect all AEs from participants within 30 minutes after each dose, collected AEs within 0-7 days after each dose (if the interval from the current dose to the next dose is less than 7 days, the collection period shall be based on the actual interval between the two doses), all non collected AEs within 30 days after the first dose to the entire dose, and all serious adverse events (SAE) within 6 months after the first dose to the entire dose.

Conditions

• Rabies Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program	Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
BIOLOGICAL	Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program	Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
BIOLOGICAL	Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program	Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
BIOLOGICAL	Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 4-dose program	Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm

Timeline

• Start date: 2019-10-19
• Primary completion: 2021-07-21
• Completion: 2022-09-26
• First posted: 2023-10-11
• Last updated: 2023-10-11

Locations

1 site across 1 country: China