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Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above — PICTPCV13i  

Bacterial Infections Clinical Trial

Official title:
A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary Evaluate the Safety and Immunogencity of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） in Healthy People Aged 6 Weeks and Above

Clinical Trial Summary

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04100772
Study type Interventional
Source CanSino Biologics Inc.
Contact
Status Completed
Phase Phase 1
Start date May 18, 2020
Completion date August 23, 2022
View Details
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