Clinical Trials Logo
  1. Home
  2. Streptococcal Infections
  3. NCT04100772

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
See also
  Status Clinical Trial Phase
Completed NCT03726216 - Xydalba Utilization Registry in France
Completed NCT03605498 - OR PathTrac (Tracking Intra-operative Bacterial Transmission)
Withdrawn NCT05269121 - Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections Phase 1/Phase 2
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Recruiting NCT02074865 - Children's Antibiotic Resistant Infections in Low Income Countries N/A
Completed NCT01689207 - To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) Phase 1
Completed NCT01932034 - Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software N/A
Completed NCT01412801 - Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings Phase 2
Not yet recruiting NCT01159470 - The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children N/A
Completed NCT00983255 - Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA) Phase 1
Completed NCT00678106 - Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections Phase 1
Completed NCT00799591 - French Study In ICU Patients Treated With Tigecycline N/A
Completed NCT01074775 - Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection N/A
Completed NCT00478855 - Tazocin Intervention Study Phase 4
Terminated NCT00431028 - Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery Phase 1/Phase 2
Not yet recruiting NCT03634904 - Serum Ceftazidime Concentrations in Hemodialysis Patients N/A
Recruiting NCT05684705 - Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 Phase 1
Recruiting NCT03858387 - PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
Enrolling by invitation NCT04764058 - Efficacy and Safety of Colistin Based Antibiotic Therapy Phase 1/Phase 2
Recruiting NCT06319235 - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG® Phase 1/Phase 2