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

Bacterial Infections Clinical Trial

— PICTPCV13i  

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 Details — Status: Completed

Administrative data

• NCT number: NCT04100772
• Other study ID #: CS-CTP-PCV
• Status: Completed
• Phase: Phase 1
• Start date: May 18, 2020
• Est. completion date: August 23, 2022

Study information

• Verified date: October 2022
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: August 23, 2022
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infections
• Pneumococcal Infections
• Streptococcal Infections

Intervention

Biological:
• 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine(CRM197,TT)
0.5mL,Intramuscular other name:PCV13i
• 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
0.5mL,Intramuscular other name:Prevnar

Locations

Country	Name	City	State
China	Neihuang Center for Disease Control and Prevention	Anyang	Henan

Sponsors (2)

Lead Sponsor	Collaborator
CanSino Biologics Inc.	Henan Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety items of adverse reactions	Occurrence of adverse reactions of each subject(Arm 1A-7B)	within 7 days post each vaccination
Primary	Safety items of SAE	Occurrence of SAE of each subject(Arm 1A-7B)	within 6 months post last vaccination
Primary	Safety items of Hematological examination	Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A)	day 4 post vaccination
Primary	Safety items of Urine test	Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A)	day 4 post vaccination
Primary	Safety items of Blood chemistry test	Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A)	day 4 post vaccination
Primary	Safety items of pressure value	Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A)	day 4 post vaccination
Primary	Safety items of heart rate	Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A)	day 4 post vaccination
Primary	Safety items of adverse reactions	Occurrence of adverse reactions of each subject(Arm 1A-7B)	within 30 days post each vaccination
Secondary	immunogencity items of seropositivity rates by ELISA	Serotype-specific seropositivity rates of Immunoglobulin G concentrations above 0.35ug/ml in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)	day 30 post last vaccination
Secondary	immunogencity items of GMC by ELISA	Serotype specific IgG GMC of each the pneumococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)	day 30 post last vaccination
Secondary	immunogencity items of GMI by ELISA	Serotype-specific GMI value pneumococcfor each of the pneunococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)	day 30 post last vaccination
Secondary	immunogencity items of GMT	Serological response in terms of GMT for each of the pneumococcal serotypes tested by OPA in subjects aged 2 months post last vaccination(7A?7B)	day 30 post last vaccination