Prevention of Rabies With Four Doses of Rabies Vaccine

Phase 3Enrolling By InvitationNCT05545371

Changchun Zhuoyi Biological Co., Ltd2,100 enrolled

Overview

To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.

* In the population aged 10-60 years, evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program (0, 3, 7, 14/28 days) over the five dose immunization program (0, 3, 7, 14, 28 days)； * To evaluate the consistency of immunogenicity between batches of freeze-dried human rabies vaccine (Vero cell) inoculated according to five dose immunization procedures (0, 3, 7, 14, 28 days).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

2,100

Conditions

Rabies Human Antibody

Interventions

immunization proceduresBIOLOGICAL

The subjects were vaccinated with rabies vaccine according to different immunization procedures

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * People aged 10-60； * Body temperature on the day of enrollment\<37.3℃ (axillary temperature) Exclusion Criteria: * Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents； * People with congenital or acquired immunodeficiency or other autoimmune diseases； * Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;

Locations (1)

Changchun Zhuoyi Biological Co., Ltd

Changchun, Jilin, China

Outcomes

Primary Outcomes

Positive conversion rate of 14 days

\- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.

Time frame: 6 months

Antibody Geometric Mean Titer (GMT) of 14 days

\- 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody .

Time frame: 6 months

Positive conversion rate of 42 days

\- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.

Time frame: 6 months

Advertise Events (AE) incidence within 1 month

\- The distribution of AE incidence in different time periods (including all, within 30 minutes, 0-3 days, 0-7 days, 8-30 days) after each dose of inoculation;

Time frame: 6 months

Serious Adverse Events (SAE) incidence within 6 months

\- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.

Time frame: 12 months

Secondary Outcomes

Antibody test of 28 days

Detection of serum neutralizing antibody 28 days after the first dose of inoculation

Time frame: 6 months

Antibody GMT of 42 days

The serum neutralized antibody GMT 42 days after the first dose of inoculation;

Time frame: 6 months

Antibody test within 12 months

Data from ClinicalTrials.gov

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