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Clinical Trial Summary

A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine.Main purpose: To evaluate the safety of the adsorbed cell-free whitening break (three components) combination vaccine;Secondary purpose: To preliminarily evaluate the immunogenicity of the adsorbed cell-free whitening break (three components) combination vaccine.


Clinical Trial Description

Main endpoint: 1. Adverse events within 30 minutes after vaccination of each test dose; 2. occurrence of solicitation adverse events within 0-7 days after vaccination of each dose; 3. The occurrence of non-solicitation adverse events within 0-30 days after vaccination for each test dose; 4. occurrence of serious adverse events 6 months after the first dose of immunization to the whole immunization. Secondary endpoint: 1. Abnormal occurrence of laboratory test indicators on day 4 after immunization between 4 and 6 years old age groups; 2. Geometrical mean concentration (GMC) or geometric mean titer (GMT) of each antibody combined with the cell-free whitening break (three components) for 30 days after the full basal immunization in the 3-month age group; 3. Geometrical mean concentration (GMC) or geometric mean titer (GMT) of each antibody combined with cell-free leucocyte (three-component) adsorption at 30 days after 18 to 24 months of age immunization. ;


Study Design


NCT number NCT05189548
Study type Interventional
Source Changchun BCHT Biotechnology Co.
Contact Xiaoping Zhu
Phone 0852-85596863
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date December 10, 2021
Completion date September 30, 2022