NCT03822767

A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a "2+1"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 '2+1'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 '2+1'sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants

Detailed description

his 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 Biotech Co., Ltd in a '2+1' 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-sIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group received wIPV-wIPV-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-sIPV-bOPV vaccination schedule	Two intramuscular injections of the investigational vaccine (0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Biotech Co., Ltd . The poliovirus (Live) vaccine type I \& type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
BIOLOGICAL	wIPV-wIPV-bOPV vaccination schedule	Two intramuscular injections of the control vaccine(0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I \& type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.

Timeline

• Start date: 2018-06-12
• Primary completion: 2018-09-20
• Completion: 2018-12-11
• First posted: 2019-01-30
• Last updated: 2019-01-31

Locations

1 site across 1 country: China