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

A Randomized, Multi-center, Controlled Clinical Trial for Evaluating the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV

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

Study Overview

• Status: Completed
• Conditions: Vaccination; Reaction - Vaccine
• Intervention / Treatment: Biological: Sabin-IPV+bOPV+bOPV; Biological: Sabin-IPV+Sabin-IPV+bOPV; Biological: Sabin-IPV+Sabin-IPV+Sabin-IPV

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 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.

• Study Type: Interventional
• Enrollment (Actual): 604
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Inner Mongolia Autonomous Region
    • Hohhot, Inner Mongolia Autonomous Region, China, 010031
      • Inner Mongolia Autonomous Region Center for Diseases Prevention and Control

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sIPV+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	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
Active Comparator: sIPV+sIPV+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	Biological: 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
Active Comparator: sIPV+sIPV+sIPV; 205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively	Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the occurrence of adverse events	analyse the numbers and rates of participants who experience adverse events following immunization	6 months

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Peking University; Hubei Provincial Center for Disease Control and Prevention; Shaanxi Provincial Center for Disease Control and Prevention; Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
• Investigators: Principal Investigator: Shaohong Yan, Inner Mongolia Autonomous Region Center for Diseases Prevention and Control

Publications and helpful links

General Publications

• Yan S, Chen H, Zhang Z, Chang S, Xiao Y, Luo L, Zhang Z, Sun L, Chen X, Yang Y, Shi X, Guo Y, Sun Y, Li H, Li N, Han S, Ma M, Yang X. Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China. Vaccine. 2020 Sep 11;38(40):6274-6279. doi: 10.1016/j.vaccine.2020.07.042. Epub 2020 Jul 31.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): January 25, 2019
• Study Completion (Actual): June 12, 2019

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 11, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 11, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: sIPV-2018XG-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No