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

NCT05189548 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-01-12

No results posted yet for this study

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.

Conditions

  • Safety、Immunogenicity

Interventions

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

Sponsors & Collaborators

  • Changchun BCHT Biotechnology Co.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2022-04-30
Completion
2022-09-30

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 NCT05189548 on ClinicalTrials.gov