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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- CanSino Biologics Inc.
- Enrollment
- 237
- Locations
- 1
- Primary Endpoint
- Safety items of heart rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Weeks to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Safety items of heart rate
Time Frame: 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
Time Frame: within 30 days post each vaccination
Occurrence of adverse reactions of each subject(Arm 1A-7B)
Safety items of Urine test
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: within 6 months post last vaccination
Occurrence of SAE of each subject(Arm 1A-7B)
Secondary Outcomes
- immunogencity items of seropositivity rates by ELISA(day 30 post last vaccination)
- immunogencity items of GMC by ELISA(day 30 post last vaccination)
- immunogencity items of GMI by ELISA(day 30 post last vaccination)
- immunogencity items of GMT(day 30 post last vaccination)