Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and evaluate the non-inferiority of investigational vaccine against a post-market inactivated polio vaccine.

Clinical Trial Description

This study is a randomized, double-blinded, and positive-controlled clinical trial. A total of 1300 infants aged 2 months will be enrolled and assigned to 4 groups in a ratio of 1:1:1:1 to receive vaccination of 3 lots of investigational sIPV and control IPV manufactured by Sanofi Pasteur S.A respectively. Each subjects should finish the three-doses primary vaccination at the schedule of 2,3,4 months of age. Thirty-days safety observation after each dose of vaccination will be carried out. Venous blood should be collected from all the subjects before and 30 days after the three-doses primary vaccination, for the neutralizing antibody assay, and further to evaluate the immunogenicity. ;

Study Design

Related Conditions & MeSH terms

Poliomyelitis

Clinical Trial Details

NCT number	NCT04386707
Study type	Interventional
Source	Sinovac Biotech Co., Ltd
Contact
Status	Completed
Phase	Phase 3
Start date	May 11, 2020
Completion date	October 20, 2020

View Details

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