Loading clinical trials...

Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

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

NCT04841369•CanSino Biologics Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above;
•Willing to provide proof of identity;
•Without vaccination history of pneumococcal vaccine;
•None-pregnancy or do not plan to pregnancy recently;;
•Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent;
•Volunteers of 8-17 years old and their guardians who willing sign informed consent;
•Able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below;
•Able and willing comply with the requirements of the protocol

Exclusion Criteria

•Volunteers whose axillary body temperature was \>37.0# before vaccination
•Volunteers who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
•Volunteers who has a history of epilepsy, convulsions or psychosis;
•Allergic person;
•Any prior administration of blood products in last 3 month;
•Any prior administration of other research medicines in last 1 month;
•Plans to participate in or is participating in any other drug clinical study;
•Any prior administration of attenuated live vaccine in last 14 days;
•Any prior administration of subunit or inactivated vaccines in last 7 days;
•Had fever before vaccination, Volunteers with temperature \>37.0°C on axillary setting;
+1 more criteria

Locations (1)

Neihuang Center for Disease Control and Prevention

Anyang, Henan, China

Key Dates

Start Date

April 13, 2021

Primary Completion Date

March 30, 2022

Completion Date

September 20, 2022

Last Updated

April 2, 2024

Enrollment

3,420

ACTUAL participants

Conditions

Pneumococcal InfectionsStreptococcal InfectionsBacterial Infections

Interventions

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

BIOLOGICAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

BIOLOGICAL

[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects

NCT04263792

Bacterial Infections

View study

RECRUITING

Factors Associated With Mortality in Streptococcal Anginosus Bacteremia

NCT07343167

Streptococcal Infections

View study

RECRUITINGPHASE2

Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

Inclusion Criteria

Exclusion Criteria

[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects

Factors Associated With Mortality in Streptococcal Anginosus Bacteremia

Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV

In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)

Use of Low-cost Molecular Diagnostic Techniques as a New Surveillance Model for Diseases Preventable by Vaccinations.

Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®