Clinical trial NCT04100772: Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Infections
Streptococcal Infections
Bacterial Infections
Keywords: PCV13
13 valent Pneumococcal conjugate vaccine
Pneumococcal Infections
Safety
Immunogenicity
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Henan Center for Disease Control and Prevention
First posted: 2019-09-24
Enrollment: 237
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety items of adverse reactions
timeFrame: within 7 days post each vaccination
measure: Safety items of SAE
timeFrame: within 6 months post last vaccination
measure: Safety items of Hematological examination
timeFrame: day 4 post vaccination
measure: Safety items of Urine test
timeFrame: day 4 post vaccination
measure: Safety items of Blood chemistry test
timeFrame: day 4 post vaccination
measure: Safety items of pressure value
timeFrame: day 4 post vaccination
measure: Safety items of heart rate
timeFrame: day 4 post vaccination
measure: Safety items of adverse reactions
timeFrame: within 30 days post each vaccination
Secondary outcomes:
measure: immunogencity items of seropositivity rates by ELISA
timeFrame: day 30 post last vaccination
measure: immunogencity items of GMC by ELISA
timeFrame: day 30 post last vaccination
measure: immunogencity items of GMI by ELISA
timeFrame: day 30 post last vaccination
measure: immunogencity items of GMT
timeFrame: day 30 post last vaccination
Other outcomes:
Locations:
city: Anyang
country: China
facility: Neihuang Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Province Center for Disease Control and Prevention
name: Xia Shengli
role: PRINCIPAL_INVESTIGATOR
References: