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

NCT03597919 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2020-06-24

No results posted yet for this study

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

Interventions

BIOLOGICAL

Sabin IPV

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.

Sponsors & Collaborators

  • Shandong Province Centers for Disease Control and Prevention

    collaborator OTHER

  • World Health Organization

    collaborator OTHER

  • Centers for Disease Control and Prevention, China

    lead OTHER_GOV

Principal Investigators

  • Zijian Feng, MD, MPH · Centers for Disease Control and Prevention, China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-28
Primary Completion
2019-09-30
Completion
2020-01-15

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03597919 on ClinicalTrials.gov