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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04054492
Other study ID # sIPV-2018XG-02
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 1, 2018
Est. completion date June 12, 2019

Study information

Verified date August 2019
Source China National Biotec Group Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.


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 groups.

Group 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old.

Group 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old.

Group 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.

Blood samples were collected before vaccination and 30 days after the third dose. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of the 3 immunization schedule groups were also monitored.


Recruitment information / eligibility

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;

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Sabin-IPV+bOPV+bOPV
202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively
Sabin-IPV+Sabin-IPV+bOPV
197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively
Sabin-IPV+Sabin-IPV+Sabin-IPV
205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively

Locations

Country Name City State
China Inner Mongolia Autonomous Region Center for Diseases Prevention and Control Hohhot Inner Mongolia Autonomous Region

Sponsors (5)

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

Country where clinical trial is conducted

China, 

Outcome

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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