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Completed

NCT Number: NCT04614597

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

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Key information

Age range

18 month–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shandong Center for Disease Control and Prevention

Jinan, China

About this study

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

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Antibody persistence

    Time frame: 1 month

    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.

Secondary outcomes

  1. Neutralizing antibody titers

    Time frame: 1 month

    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

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention, China

Other Gov

Collaborators

  • Shandong Province Centers for Disease Control and Prevention
  • World Health Organization

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 4, 2020
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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