PICTPCV13i: Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above

Sponsor

CanSino Biologics Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04100772

Collaborator

Henan Center for Disease Control and Prevention (Other)

237

Enrollment

Location

Arms

19.1

Anticipated Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Infections Streptococcal Infections Bacterial Infections	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

237 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

May 18, 2020

Anticipated Primary Completion Date :

Sep 20, 2021

Anticipated Study Completion Date :

Dec 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vaccine 1A Subjects received one dose of PCV13i at 18 to 49 years old	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） 0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 2A Subjects received one dose of PCV13i at 50 years old and above	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） 0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 3A Subjects received one dose of PCV13i at 6 to 17 years old	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） 0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 4A Subjects received one dose of PCV13i at 2 to 5 years old	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） 0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 5A Subjects received two doses of PCV13i at 7 months to 2 years old	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） 0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 6A Subjects received three doses of PCV13i at 3,4,5 months of age	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） 0.5mL,Intramuscular other name:PCV13i
Experimental: vaccine 7A Subjects received three doses of PCV13i at 2,4,6 months of age	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） 0.5mL,Intramuscular other name:PCV13i
Active Comparator: vaccine 7B Subjects received three doses of PCV13 at 2,4,6 months of age	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine 0.5mL,Intramuscular other name:Prevnar

Outcome Measures

Primary Outcome Measures

Safety items of adverse reactions [within 7 days post each vaccination]
Occurrence of adverse reactions of each subject(Arm 1A-7B)
Safety items of SAE [within 6 months post last vaccination]
Occurrence of SAE of each subject(Arm 1A-7B)
Safety items of Hematological examination [day 4 post vaccination]
Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A)
Safety items of Urine test [day 4 post vaccination]
Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A)
Safety items of Blood chemistry test [day 4 post vaccination]
Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A)
Safety items of pressure value [day 4 post vaccination]
Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A)
Safety items of heart rate [day 4 post vaccination]
Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A)
Safety items of adverse reactions [within 30 days post each vaccination]
Occurrence of adverse reactions of each subject(Arm 1A-7B)

Secondary Outcome Measures

immunogencity items of seropositivity rates by ELISA [day 30 post last vaccination]
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)
immunogencity items of GMC by ELISA [day 30 post last vaccination]
Serotype specific IgG GMC of each the pneumococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)
immunogencity items of GMI by ELISA [day 30 post last vaccination]
Serotype-specific GMI value pneumococcfor each of the pneunococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)
immunogencity items of GMT [day 30 post last vaccination]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Weeks and Older

Sexes Eligible for Study:

All

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