NCT05189548

To Evaluate the Safety and Primary Immunogenicity of Cell-free (Three-component) Combination Vaccine for Phase I Immunogenicity in Children and Infants

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Changchun BCHT Biotechnology Co. · Industry
• Sex: All
• Age: 3 Months – 6 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Safety、Immunogenicity

Interventions

Type	Name	Description
BIOLOGICAL	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	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

Timeline

• Start date: 2021-12-10
• Primary completion: 2022-04-30
• Completion: 2022-09-30
• First posted: 2022-01-12
• Last updated: 2022-01-12

Locations

1 site across 1 country: China