To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054492
• Other study ID #: sIPV-2018XG-02
• Status: Completed
• Phase: Phase 4
• 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
• 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;

Related Conditions & MeSH terms

• Reaction - Vaccine
• Vaccination

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