Bacterial Infections Clinical Trial
— PICTPCV13iOfficial 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
Verified date | October 2022 |
Source | CanSino Biologics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Neihuang Center for Disease Control and Prevention | Anyang | Henan |
Lead Sponsor | Collaborator |
---|---|
CanSino Biologics Inc. | Henan Center for Disease Control and Prevention |
China,
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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