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

NCT04100772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2022-10-31

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

0.5mL,Intramuscular other name:PCV13i

BIOLOGICAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

0.5mL,Intramuscular other name:Prevnar

Sponsors & Collaborators

  • Henan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Xia Shengli · Henan Province Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-18
Primary Completion
2021-06-23
Completion
2022-08-23

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04100772 on ClinicalTrials.gov