Status:
COMPLETED
Immunogenicity and Safety of Sabin-IPV Replacement Vaccination
Lead Sponsor:
China National Biotec Group Company Limited
Collaborating Sponsors:
Beijing Institute of Biological Products Co Ltd.
Beijing Center for Disease Control and Prevention
Conditions:
Vaccination
Eligibility:
All Genders
60-89 years
Phase:
PHASE4
Brief Summary
This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scient...
Detailed Description
It is required by China Food and Drug Administration (CFDA) that considering in the real situation IPV receivers may be immuned by different viral strains of this vaccine, a phase 4 clinical trial aim...
Eligibility Criteria
Inclusion
- subjects aged from 60 days to 89 days old at the date of recruitment;
- with informed consent signed by parent(s) or guardians;
- parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
- subjects did not receive any vaccines within 14 days;
- axillary temperature ≤37.0℃
Exclusion
- allergic to any ingredient of vaccine or with allergy history to any vaccine;
- acute febrile disease or infectious disease;
- serious chronic diseases;
- any other factor that makes the investigator determines the subject is unsuitable for this study;
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04051736
Start Date
March 1 2018
End Date
August 31 2020
Last Update
September 9 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Center for Disease Control and Prevention
Beijing, Beijing Municipality, China, 100013