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

Last updated: April 1, 2024
Sponsor: CanSino Biologics Inc.
Overall Status: Completed

Phase

3

Condition

Bacterial Infections

Pressure Ulcers

Treatment

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

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Clinical Study ID

NCT04841369
CS-CTP-PCV-III
  • Ages > 6
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 clinicalstudie 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 forthe volunteers of 8 years old and below;
  • Able and willing comply with the requirements of the protocol

Exclusion

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;
  • According to the investigator's judgement, the subjects have any other factors thatmake them unfit to enroll the clinical trial

Study Design

Total Participants: 3420
Treatment Group(s): 2
Primary Treatment: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT)
Phase: 3
Study Start date:
April 13, 2021
Estimated Completion Date:
September 20, 2022

Connect with a study center

  • Neihuang Center for Disease Control and Prevention

    Anyang, Henan 450016
    China

    Site Not Available

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