NCT02985320

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

A Open-label Phase I Study to Evaluate Safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Adults, Children, and Infants, and a Blinded, Randomized and Controlled Phase II to Evaluate Safety and Immunogenicity of it in Infants

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 708 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 2 Months – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-12-07
• Last updated: 2017-07-26

Locations

1 site across 1 country: China