A Study on Immunity Duration Against Polio Over 18 Months Infants After 2 or 3 Primary Doses Sabin IPV in China

A Study on Immunity Duration Against Polio Over 18 Months Infants After 2 or 3 Primary Doses Sabin Strain Inactivated Poliovirus Vaccine in China

In 2017, China CDC conducted a study titled "A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China". At present, all the infants in the monitoring cohort were over 18 months old and at least one year had elapsed since the last dose of sIPV inoculation.Since there is no any data about the protection duration of two-dose Sabin IPV schedules, China CDC propose to follow up the study cohort to evaluate the proportion of seroprotection of antibody and measure neutralizing antibody titers against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in Chinese children.

Study Overview

• Status: Completed
• Conditions: Poliomyelitis
• Intervention / Treatment: Biological: Sabin strain inactivated polio vaccine

Detailed Description

In 2017, China CDC conducted a study titled "A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China". This study offers evidence that two doses of sIPV administered at 4 and 8-11 months of age and three doses of sIPV administered at 2, 3, and 4 months of age both provide serological protection against poliomyelitis. At present, all the infants in the monitoring cohort were over 18 months old and at least one year had elapsed since the last dose of sIPV inoculation.

Since there is no any data about the protection duration of two-dose Sabin IPV schedules, China CDC propose to follow up the study cohort when all subjects are at least 18 months old to monitor persistence of antibody. So that, if the antibody levels are not high enough to protect children from the disease, remedial measures can be taken as soon as possible.So China CDC conduct this follow up study ,to

1. Evaluate the proportion of seroprotection of antibody against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in Chinese children.
2. Measure neutralizing antibody titers against poliovirus type I, II and III at over 18 months of age infants after 2-dose Sabin IPV schedule, compared with 3-dose Sabin IPV schedule.

• Study Type: Observational
• Enrollment (Actual): 774

Contacts and Locations

Study Locations

• China
  • Jinan, China
    • Shandong Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children who had participated the previous Sabin IPV study in 6 counties in Shandong province.

Description

Inclusion Criteria:

• Parent or legal guardian agree to participate in the follow study.
• The subject was vaccinated either two doses or three doses Sabin IPV ,collected two blood samples and laboratory test results were available per protocol of pervious study
• The subject is at least 18 months age.

Exclusion Criteria:

• Parent or legal guardian does not agree to participate in the follow up study.
• The subject has received any polio vaccine product beyond the protocol of previous study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Three-dose schedule for Sabin IPV; Subjects already vaccinated Sabin IPV at 2, 3, and 4 months of age, collected two blood samples and laboratory test results were available.	Biological: Sabin strain inactivated polio vaccine; Sabin IPVs have been given to participants in previously study, blood specimens will be collected once all the subjects reach the age of 18months.
Two-dose schedule for Sabin IPV; Subjects already vaccinated Sabin IPV at 4 and 8-11 months of age, collected two blood samples and laboratory test results were available.	Biological: Sabin strain inactivated polio vaccine; Sabin IPVs have been given to participants in previously study, blood specimens will be collected once all the subjects reach the age of 18months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody persistence	Evaluate the proportion of seroprotection of antibody against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in Chinese children.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutralizing antibody titers	Measure neutralizing antibody titers against poliovirus type I, II and III at over 18 months of age infants after 2-dose Sabin IPV schedule, compared with 3-dose Sabin IPV schedule	1 month

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention, China
• Collaborators: World Health Organization; Shandong Province Centers for Disease Control and Prevention
• Investigators: Study Chair: Zijian Feng, MD, Centers for Disease Control and Prevention, China; Principal Investigator: Zhijie An, MPH, Centers for Disease Control and Prevention, China; Study Director: Zundong Yin, Centers for Disease Control and Prevention, China

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Sabin strain; Inactivated Poliovirus Vaccine
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis
• Other Study ID Numbers: 201935

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