Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine

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

PHASE4

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-11

Study Completion Date

2021-11-08

Brief Summary

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Evaluation of immune persistence after rabies vaccination in 150 people.

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Detailed Description

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150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (Vero cells) produced and marketed by Changchun Zhuoyi Biological Co., Ltd. in the whole process of 0, 3, 7, 14 and 28 day immunization. The immunogenicity persistence and safety of the test vaccine were evaluated 14 days, 6 months and 12 months after the whole process of vaccination.

Conditions

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Rabies Antibody

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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experimental arm

5 doses of rabies vaccine

Group Type EXPERIMENTAL

5 doses program

Intervention Type BIOLOGICAL

Inoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody

Interventions

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5 doses program

Inoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 10-60 years old；
* Temperature on the day of admission≤37.0 ° C (axillary temperature).

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