Status:
COMPLETED
Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above
Lead Sponsor:
CanSino Biologics Inc.
Collaborating Sponsors:
Henan Center for Disease Control and Prevention
Conditions:
Pneumococcal Infections
Streptococcal Infections
Eligibility:
All Genders
6+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2022
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT04100772
Start Date
May 18 2020
End Date
August 23 2022
Last Update
October 31 2022
Active Locations (1)
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1
Neihuang Center for Disease Control and Prevention
Anyang, Henan, China, 450016