NCT04614597

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 774 (actual)
• Sponsor: Centers for Disease Control and Prevention, China · Other Government
• Sex: All
• Age: 18 Months – 3 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-29
• Primary completion: 2021-12-21
• Completion: 2021-12-21
• First posted: 2020-11-04
• Last updated: 2022-03-09

Locations

1 site across 1 country: China