Clinical trial NCT04841369: Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)
Official title: A Randomized,Blind, Positive-controlled Phase III Clinical Trial to 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: PHASE3
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: 2021-04-12
Enrollment: 3420
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 of PCV13i in preventing pneumococcal infections
timeFrame: Within 7 days post each vaccination
measure: Safety of PCV13i in preventing pneumococcal infections
timeFrame: Within 30 days post each vaccination
measure: Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
timeFrame: 30 days post three doses
measure: Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B)
timeFrame: 30 days post three doses
measure: Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B)
timeFrame: 30 days post last dose of vaccination
measure: Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)
timeFrame: 30 days post vaccination
Secondary outcomes:
measure: Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
timeFrame: 30 days post three doses
measure: Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
timeFrame: 30 days post three doses
measure: Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
timeFrame: 6 months post one to three doses of vaccination
measure: Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B)
timeFrame: 30 days post two doses
measure: Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
timeFrame: 30 days post last dose of vaccination
measure: Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B)
timeFrame: 30 days post two doses
measure: Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
timeFrame: 30 days post last dose of vaccination
measure: Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B)
timeFrame: 6 months post two doses
measure: Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
timeFrame: 6 months post last dose of 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: Shengli Xia
role: PRINCIPAL_INVESTIGATOR
References: