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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04100772
Other study ID # CS-CTP-PCV
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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