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Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine

NCT02985320 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 708

Last updated 2017-07-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

Single-dose regimen of high dosage investigational sIPV

The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..

BIOLOGICAL

Single-dose regimen of medium dosage investigational sIPV

The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..

BIOLOGICAL

Three-dose regimen of high dosage investigational sIPV

The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..

BIOLOGICAL

Three-dose regimen of medium dosage investigational sIPV

The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..

BIOLOGICAL

Three-dose regimen of low dosage investigational sIPV

The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..

BIOLOGICAL

Three-dose regimen of commercialized sIPV

The control vaccine was manufactured by Chinese Academy of Medical Sciences.

BIOLOGICAL

Three-dose regimen of commercialized IPV

The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yuemei Hu · Jiangsu Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-06-30
Completion
2017-06-30

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 NCT02985320 on ClinicalTrials.gov