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Immunogenicity and Safety of A Lyophilized Purified Human Diploid Cell Rabies Vaccine .

NCT03971370 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2019-06-03

No results posted yet for this study

Summary

Rabies is caused by rabies virus with a 100% mortality rate in humans. Most of cases occur in Africa and Asia, mainly in underserved populations. Rabies is a vaccine-preventable disease in both humans and animals. The WHO clearly states that human diploid cell rabies vaccine is the "gold standard" rabies vaccine, because of no carcinogenicity and any foreign animal impurity or neurotoxicity factor. China does not approve the import of foreign HDCV and has insufficiency domestic HDCV, so this clinic trial was to assess the immunogenicity and safety of HDCV in healthy population for the large-scale developing of a lyophilized and purified HDCV.

Conditions

  • Adverse Effect and Immunogenicity of Vaccine

Interventions

BIOLOGICAL

Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)

Essen post-exposure immunization schedule at day 0,3,7,14,28.

BIOLOGICAL

Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)

Zagreb post-exposure immunization schedule at day 0,7,21.

BIOLOGICAL

Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.)

Essen post-exposure immunization schedule at day 0,3,7,14,28.

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Principal Investigators

  • Yuemei Hu, Master · Jiangsu Provincial Center for Diseases Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-10
Primary Completion
2018-09-29
Completion
2019-02-22

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03971370 on ClinicalTrials.gov