A Clinical Trial of Freeze-dried Human Rabies Vaccine (MRC-5 Cells)
Condition: Rabies Vaccine Adverse Reaction
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program; Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program; Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program; Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 4-dose program
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm; 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; Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm; 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
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Similar vaccine control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Efficacy