Vaccine Prevention of Rabies Adopts 4-shot Immunization Method

Changchun Zhuoyi Biological Co., Ltd1,800 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,800

Conditions

Rabies Human Antibody Titer

Interventions

rabies vaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 10 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Changchun Zhuoyi Biological Co., Ltd

Changchun, Jilin, China

Outcomes

Primary Outcomes

Antibody positive conversion rate of experimental groups

\- Compare the Antibody positive conversion rate between two experimental groups 14 days after the first dose of inoculation.

Time frame: 3 months

Antibody positive conversion rate of 4 doses groups

-Compare the Antibody positive conversion rate between the SPEEDA 4 doses group and experimental 4 doses group 14 days after the first dose of inoculation.

Time frame: 3 months

Compare the GMT between two experimental groups

\- Compare the GMT between two experimental groups 14 days after the first dose of inoculation.

Time frame: 3 months

Geometric Mean Titer (GMT) of 4 doses groups

\- Compare the GMT between the SPEEDA 4 doses group and the experimental 4 doses group 14 days after the first dose inoculation.

Time frame: 3 months

Safety within 30 minutes

\- Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation;

Time frame: 3 months

Safety within 0-7 days

\- Incidence rate of collected AE within 0-7 days after each dose of inoculation;

Time frame: 3 months

Safety within 6 months

\- Incidence rate of all serious adverse events (SAE) within 6 months from the first dose of inoculation to the full course of inoculation.

Time frame: 9months

Secondary Outcomes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.