Vaccination Clinical Trial
Official title:
A Randomized, Multi-center, Controlled Clinical Trial for Evaluating the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
Verified date | August 2019 |
Source | China National Biotec Group Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.
Status | Completed |
Enrollment | 604 |
Est. completion date | June 12, 2019 |
Est. primary completion date | January 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Days to 89 Days |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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; |
Country | Name | City | State |
---|---|---|---|
China | Inner Mongolia Autonomous Region Center for Diseases Prevention and Control | Hohhot | Inner Mongolia Autonomous Region |
Lead Sponsor | Collaborator |
---|---|
China National Biotec Group Company Limited | Hebei Provincial Center for Diseases Prevention and Control, Inner Mongolia Autonomous Region Center for Diseases Prevention and Control, Peking University, Shanxi Provincial Center for Disease Control and Prevention |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | the occurrence of adverse events | analyse the numbers and rates of participants who experience adverse events following immunization | 6 months | |
Primary | Seroconversion rates at both baseline and 30 days after the 3rd vaccination | Determine the seroconversion rates of poliovirus (types I,II,III)at both baseline and 30 days after the 3rd vaccination | 4 months | |
Secondary | Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination | Measure neutralizing antibody titers against poliovirus type I, II and III at both baseline and 30 days after the 3rd vaccination | 4 months |
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