Status:
COMPLETED
To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
Lead Sponsor:
China National Biotec Group Company Limited
Collaborating Sponsors:
Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
Shaanxi Provincial Center for Disease Control and Prevention
Conditions:
Vaccination
Reaction - Vaccine
Eligibility:
All Genders
60-89 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.
Detailed Description
A phase 4 clinical trial is designed to evaluate the safety and immunogenicity of different sequential immunization schedules of Sabin IPV and bOPV. To be specific, the subjects were divided into 3 gr...
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 vaccination 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 :
June 12 2019
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT04054492
Start Date
March 1 2018
End Date
June 12 2019
Last Update
August 13 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
Hohhot, Inner Mongolia, China, 010031