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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    3420
  • sponsor
    CanSino Biologics Inc.
Updated on 12 August 2021
vaccination
pneumococcal
polysaccharide
conjugate vaccine
pneumococcal vaccine

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.

Details
Condition streptococcus pneumoniae infections, Bacterial Infections, Strep Throat, streptococcal infections, pneumococcal infections, Pneumococcal infection, bacterial disease, Bacterial Infection, Streptococcal infection, Pneumococcal Disease, strep
Treatment 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT), 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
Clinical Study IdentifierNCT04841369
SponsorCanSino Biologics Inc.
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

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 >37.0C on axillary setting
According to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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