Safety?Immunogenicity Clinical Trial
Official title:
To Evaluate the Safety and Primary Immunogenicity of Cell-free (Three-component) Combination Vaccine for Phase I Immunogenicity in Children and Infants
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.
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. ;