Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above
- Conditions
- Streptococcal InfectionsBacterial InfectionsPneumococcal Infections
- Interventions
- Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
- Registration Number
- NCT04100772
- Lead Sponsor
- CanSino Biologics Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 237
- 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 ;
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vaccine 3A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subjects received one dose of PCV13i at 6 to 17 years old vaccine 2A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subjects received one dose of PCV13i at 50 years old and above vaccine 1A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subjects received one dose of PCV13i at 18 to 49 years old vaccine 7B 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine Subjects received three doses of PCV13 at 2,4,6 months of age vaccine 4A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subjects received one dose of PCV13i at 2 to 5 years old vaccine 5A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subjects received two doses of PCV13i at 7 months to 2 years old vaccine 6A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subjects received three doses of PCV13i at 3,4,5 months of age vaccine 7A 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） Subjects received three doses of PCV13i at 2,4,6 months of age
- Primary Outcome Measures
Name Time Method 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)
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 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 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 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 SAE within 6 months post last vaccination Occurrence of SAE of each subject(Arm 1A-7B)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Neihuang Center for Disease Control and Prevention
🇨🇳Anyang, Henan, China