Vaccine Prevention of Rabies Adopts 4-shot Immunization Method

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-22

Study Completion Date

2023-04-20

Brief Summary

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A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)

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Detailed Description

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It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination.

To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.

Conditions

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Rabies Human Antibody Titer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental 4 doses

Inoculate experimental vaccine according to 2-1-1 immunization procedure

Group Type EXPERIMENTAL

rabies vaccine

Intervention Type BIOLOGICAL

The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared

Experimental 5 doses

Inoculate experimental vaccine according to 1-1-1-1-1 immunization procedure

Group Type EXPERIMENTAL

rabies vaccine

Intervention Type BIOLOGICAL

The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared

SPEEDA® 4 doses

Inoculate SPEEDA® according to 2-1-1 immunization procedure

Group Type ACTIVE_COMPARATOR

rabies vaccine

Intervention Type BIOLOGICAL

The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared

Interventions

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rabies vaccine

The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* The age is 10-60 years old;
* Underarm temperature ≤ 37.0 ℃.

Exclusion Criteria

* Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
* Has been diagnosed with congenital or acquired immunodeficiency disease；
* Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.

Minimum Eligible Age

10 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes