A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China.

NCT03597919 | Completed Phase 4

• 1 other identifier: 201717
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

In April 2017, WHO recommended that a two-dose, Inactivated Poliovirus Vaccine, IPV-only schedule at 4 months and 8 months of age can be used after polio eradication, with a schedule seroconversion target of at least 90%. However, there is no such data for China domestic Sabin strain IPVs to support a 2-dose schedule among Chinese infants. This research is to determine the seroconversion rates among two arms: Group 1: two-dose schedule, infants will be received two doses of Sabin IPV, the first dose at 4 month of age, and the second dose at 8-11 month of age. Group 2: three-dose schedule, infants will be received three doses of Sabin IPV at 2, 3 and 4 month of age respectively. This schedule is currently recommended by manufacture's package insert for routine use. The hypothesis is the seroconversion will be above 90% in both groups.

Conditions

Poliomyelitis

Keywords

Inactivated Poliovirus Vaccine; Sabin strain

Outcome Measures

Primary Outcomes (1)

• Seroconversion rate

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

  10 months

Secondary Outcomes (1)

• Neutralizing antibody titers

  10 months

Study Arms (2)

Three-dose schedule for Sabin IPV

ACTIVE COMPARATOR

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.

Biological: Sabin IPV

Two-dose schedule for Sabin IPV

EXPERIMENTAL

Subjects vaccinate first dose IPV at 4 months, 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.

Biological: Sabin IPV

Interventions

Sabin IPV BIOLOGICAL

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

Also known as: Sabin strain Inactivated Poliovirus Vaccine

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

Eligibility Criteria

• Age: 2 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Shandong Center for Disease Control and Prevention

Jinan, China

Location

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, MPH

  Centers for Disease Control and Prevention, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vaccine Evaluation Division, National Immunization Program

Model Details: a multi-center, randomized, open-label, seroconversion/immunogenicity study.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: July 24, 2018
• Study Start: May 28, 2018
• Primary Completion: September 30, 2019
• Study Completion: January 15, 2020
• Last Updated: June 24, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)