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

NCT04614597 | Completed

• 1 other identifier: 201935
• Study Type: observational
• Target: 774
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Poliomyelitis

Keywords

Inactivated Poliovirus Vaccine; Sabin strain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neutralizing antibody titers

  1 month

Study Arms (2)

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

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

Interventions

Sabin strain inactivated polio vaccine BIOLOGICAL

Sabin IPVs have been given to participants in previously study, blood specimens will be collected once all the subjects reach the age of 18months.

Three-dose schedule for Sabin IPV; Two-dose schedule for Sabin IPV

Eligibility Criteria

• Age: 18 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention, China: lead
• World Health Organization: collaborator
• Shandong Province Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Shandong Center for Disease Control and Prevention

Jinan, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Zijian Feng, MD

  Centers for Disease Control and Prevention, China

  STUDY CHAIR

• Zhijie An, MPH

  Centers for Disease Control and Prevention, China

  PRINCIPAL INVESTIGATOR

• Zundong Yin

  Centers for Disease Control and Prevention, China

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher of National Immunization Program

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 4, 2020
• Study Start: October 29, 2020
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)