NCT03822754

A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a '1+2' Sequential Schedule With bOPV in Infants

A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in a '1+2' Sequential Schedule With Bivalent Oral Poliovirus Vaccine in 2-month-old Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 60 Days – 90 Days
• Healthy volunteers: Accepted

Summary

The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '1+2' sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants

Detailed description

This study is a randomized, double-blind, active-controlled phrase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of sIPV manufactured by Sinovac Vaccine Technology Co., Ltd in a '1+2' sequential schedule with bOPV in 2-month-old infants. 240 infants aged between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1. The experimental group received sIPV-bOPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group received wIPV-bOPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2). The control wIPV was manufactured by SANOFI PASTEUR S.A.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	sIPV-bOPV-bOPV vaccination schedule	Single intramuscular injection of the experimental sIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Vaccine Technology Co., Ltd. The poliovirus (Live) vaccine type I \& type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
BIOLOGICAL	wIPV-bOPV-bOPV vaccination schedule	Single intramuscular injection of the control wIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively.The control wild strain inactivated poliovirus vaccine (wIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I \& type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.

Timeline

• Start date: 2018-06-06
• Primary completion: 2018-09-26
• Completion: 2018-12-11
• First posted: 2019-01-30
• Last updated: 2019-01-30

Locations

1 site across 1 country: China