Sero-conversion Study for a Two-dose Schedule of Sabin IPV in China

NCT ID: NCT03546634

Last Updated: 2020-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-24
• Study Completion Date: 2020-01-15

Brief Summary

This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.

The overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.

Detailed Description

In April 2017, WHO/SAGE recommended that a two-dose, IPV-only schedule can be used after polio eradication, with a schedule seroconversion target of at least 90%. The recommendation was based in part on a study conducted in Cuba using Salk-IPV at 4 months and 8 months of age. However, for domestic Sabin IPVs, there are no such data to support a 2-dose schedule among Chinese infants.Two Sabin IPV products that are available to China's National Immunization Program - produced by Kunming Bio institute and China National Biotec Group (CNBG).The monitoring study on sIPV produced by Kunming Bio institute has already applied for approval.This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.

The overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.

The specific objectives of the study are to:

1. Determine whether the seroconversion rate is above 90% with a 2-dose Sabin IPV schedule, with the first dose given at 4 months and the second dose given ≥4 months after the first dose.

2. Measure neutralizing antibody titers against poliovirus type I, II and III among two-dose Sabin IPV alone schedule, compared with three-dose Sabin IPV alone schedule.

Conditions

Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Three-dose schedule for Sabin IPV

Subjects vaccinate Sabin IPV at 2, 3, and 4 months of age,will be collected blood specimens twice - right before the first dose of IPV, and one month after the 3rd dose of IPV.

Group Type: ACTIVE_COMPARATOR

Sabin IPV

Intervention Type: BIOLOGICAL

We select one Sabin IPV product, produced by China National Biotec Group, which is available for China's National Immunization Program in the selected study sites.

Two-dose schedule for Sabin IPV

Subjects first dose IPV vaccinate at 4 months of age, and the second dose IPV given between 8 and 11 months of age,will be collected blood specimens twice - right before the first dose of IPV, and one month after the 2nd dose of IPV.

Group Type: EXPERIMENTAL

Sabin IPV

Intervention Type: BIOLOGICAL

We select one Sabin IPV product, produced by China National Biotec Group, which is available for China's National Immunization Program in the selected study sites.

Interventions

Sabin IPV

We select one Sabin IPV product, produced by China National Biotec Group, which is available for China's National Immunization Program in the selected study sites.

Intervention Type: BIOLOGICAL

Other Intervention Names

Sabin strain Inactivated Poliovirus Vaccine

Eligibility Criteria

Inclusion Criteria

• Parent or legal guardian agree to participate in our study.
• The family is living locally with legal residency status.

Exclusion Criteria

• Parent or legal guardian does not agree to participate in our study.
• The potential subject has received IPV or OPV before 4 months of age in the two-dose schedule group.
• The potential subject has one or more contraindications to IPV (although we will note the contraindications).

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong Province Centers for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention, China

OTHER_GOV

Sponsor Role: lead

Responsible Party

AN Zhijie

Director of Vaccine Evaluation Division, National Immunization Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zijian Feng

Role: STUDY_CHAIR

Centers for Disease Control and Prevention, China

Locations

Shandong Center for Disease Control and Prevention

Jinan, , China

Countries

China

Other Identifiers

201806

Identifier Type: -

Identifier Source: org_study_id