Prevention of Rabies With Four Doses of Rabies Vaccine

NCT ID: NCT05545371

Last Updated: 2024-07-10

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

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

2100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-18

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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* 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).

Conditions

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Rabies Human Antibody

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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4 doses

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

Group Type EXPERIMENTAL

immunization procedures

Intervention Type BIOLOGICAL

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

5 doses

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

Group Type EXPERIMENTAL

immunization procedures

Intervention Type BIOLOGICAL

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

Interventions

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immunization procedures

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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;
Minimum Eligible Age

10 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changchun Zhuoyi Biological Co., Ltd

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Miao

Role: STUDY_DIRECTOR

Changchun Zhuoyi Biological Co., Ltd

Locations

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Changchun Zhuoyi Biological Co., Ltd

Changchun, Jilin, China

Site Status

Countries

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China

Other Identifiers

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ZY202106001

Identifier Type: -

Identifier Source: org_study_id

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