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

Poliomyelitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04614597
• Other study ID #: 201935
• Status: Completed
• Start date: October 29, 2020
• Est. completion date: December 21, 2021

Study information

• Verified date: March 2022
• Source: Centers for Disease Control and Prevention, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 774
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

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.

Locations

Country	Name	City	State
China	Shandong Center for Disease Control and Prevention	Jinan

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention, China	Shandong Province Centers for Disease Control and Prevention, World Health Organization

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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