Randomized, Blind and Positive Control Design: a Phase III Clinical Trial to Evaluate the Consistency Between Batches of 5 Doses of Freeze-dried Rabies Vaccine (Vero Cell) and the Immunogenicity and Safety of 4 Doses of Vaccine (1-1-1-1)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    2100
  • sponsor
    Changchun Zhuoyi Biological Co., Ltd
Updated on 21 October 2022
Accepts healthy volunteers

Summary

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.

Description

  • 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).

Details
Condition Rabies Human, Antibody
Treatment immunization procedures
Clinical Study IdentifierNCT05545371
SponsorChangchun Zhuoyi Biological Co., Ltd
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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
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