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

NCT03546634 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2020-06-24

No results posted yet for this study

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.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • Shandong Province Centers for Disease Control and Prevention

    collaborator OTHER

  • Centers for Disease Control and Prevention, China

    lead OTHER_GOV

Principal Investigators

  • Zijian Feng · 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
2018-05-24
Primary Completion
2019-06-05
Completion
2020-01-15

Countries

  • China

Study Locations

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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 NCT03546634 on ClinicalTrials.gov